Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound transducer and explicitly states that the technology for imaging, doppler functions, and signal processing is the same as predicate devices, with no mention of AI or ML.

Therapeutic

No
The device is clearly indicated for "diagnostic ultrasound evaluation," which implies imaging and assessment, not treatment.

Diagnostic

Yes
The 'Intended Use / Indications for Use' section explicitly states that the transducers are for "diagnostic ultrasound evaluation."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Linear Array transducer," which is a hardware component used in ultrasound systems. The summary also describes physical testing of the transducer (Grasp and Release Test, Bend and Flexibility Test).

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "diagnostic ultrasound evaluation during robotic and non-robotic intra-operative and laparoscopic procedures." This describes a device used in vivo (within the body) for imaging and diagnosis, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue samples.
Device Description: It is described as a "Linear Array transducer," which is a component of an ultrasound system used for generating and receiving ultrasound waves to create images of internal structures.
Input Imaging Modality: The input modality is "Diagnostic ultrasound," which is an imaging technique performed on a living patient.
Anatomical Site: The anatomical site includes "imaging of organs and structures exposed during surgery," again indicating in vivo use.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The UST-5550-R and UST-5536-R transducer is intended for use with the PROSOUND ALPHA 7 Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for the diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. The L43K transducer is intended for use with the ARIETTA60, ARIETTA 70 and NOBLUS Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures. This device is not indicated for Ophthalmic applications. *For robotic use, these devices can only be used with the da Vinci™ Surgical System and da Vinci™ 8 mm ProGrasp Forceps. **For non-robotic use, these devices can only be used with the Covidien SILST™ Clinch

Product codes

ITX

Device Description

Linear Array transducer

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Diagnostic Ultrasound

Anatomical Site

includes imaging of organs and structures exposed during surgery.
imaging of organs and structures exposed during surgery, including "open" and laparoscopic procedures.
includes imaging of organs and structures exposed during "a" laparotomy.
including major organs and structures exposed during autopsy.
including structures and organs of the body exposed during surgery.
• Includes imaging of organs and structures exposed during laparotomy (exploratory laparotomy, exploratory laparoscopy, or open abdominal approach)
includes images of drains and structures exposed during demolition.
includes images of organs and structures exposed during surgery.
Includes images of organs and structures exposed during abdominal dissection.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained personnel (doctor, sonography, etc.) for the diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing: No new hazards were identified with the modification to the scanning head. The bend and flexibility durability testing demonstrates that the material change to Titanium of the transducer head shell and the "T' attaching mechanism design to all the option grasping the transducer head by either a da Vinci 8mm ProGrasp grasping mechanism or Covidien SILS manual grasper instruments for intra-operative or laparoscopic procedure scanning does not add any additional risk nor effect image quality.
Test: Grasp and Release Test with da Vinci 8 mm ProGrasp robotic arm. Acceptance Criteria: Grasp and release with UST-5550-R /L43K the 8mm ProGrasp robotic arm starting straight, 180° and straight and releasing 100/500 times. The L43K must complete the testing without loss of imaging performance or broken and/or loose components. Result: Pass – after completing 100 and 500 grasp and release movements there is no signs of physical damage and no changes in imaging performance.
Test: Bend and Flexibility Test with da Vinci 8 mm ProGrasp robotic arm. Acceptance Criteria: Bend and Release with UST-5550-R /L43K with da Vinci S and Prograsp 8mm Forceps. All Robotic Ultrasound Probe samples must complete 500/1000 random articulations in a north, south, east and west direction without loss of imaging performance, broken and/or loose components. Result: Pass - after completing 500 and 1000 random articulations in a north, south, east and west direction there were no broken and/or loose components and no loss of imaging performance.

Clinical testing: None required

Conclusion: The UST-5550-R, UST-5536-R and L43K Transducers is substantially equivalent in safety and effectiveness to the predicate device(s); The subject and predicate device(s) are both indicated for inter-operative diagnostic ultrasound imaging. The subject and predicate device(s) have the same gray scale and doppler capabilities. The subject and predicate device(s) have the same essential technology for imaging, doppler functions and signal processing. The subject and predicate device(s) have acoustic level below the Track 3 FDA limits. The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820 Quality System Regulations. The subject and predicate device(s) are designed and manufactured to the same electrical and physical safety standards. The subject and predicate device(s) are manufactured with materials that have been tested in accordance to ISO 10993-1; all biocompatibility testing has been conducted in accordance to each component material characterization, type of body contact, and duration contact risk profile. The subject and predicate device(s) are supplied non-sterile with instructions for cleaning, disinfection and sterilization in the transducer manuals.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K111227, K142368

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. To the left of the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 17, 2016

Hitachi Aloka Medical America, Inc. % Ms. Angela Van Arsdale RA/QA Manager 10 Fairfield Blvd. WALLINGFORD CT 06492-5903

Re: K152126

Trade/Device Name: UST-5550-R: UST-5536-R: L43K Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: ITX Dated: August 2, 2016 Received: August 3, 2016

Dear Ms. Van Arsdale:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)	K152126
Device Name
UST-5550-R
UST-5536-R
L43K
Indications for Use (Describe)
The UST-5550-R and UST-5536-R transducer is intended for use with the PROSOUND ALPHA 7 Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for the diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures.
The L43K transducer is intended for use with the ARIETTA60, ARIETTA 70 and NOBLUS Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic procedures.
This device is not indicated for Ophthalmic applications.
*For robotic use, these devices can only be used with the da Vinci™ Surgical System and da Vinci™ 8 mm ProGrasp Forceps.
**For non-robotic use, these devices can only be used with the Covidien SILST™ Clinch

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740

EF

网

065

3

ISOF ECU SOF SMOITACIONI ANUOSAAT JU OITSOMDAIO

: 1991 ps น ธ 1 T Device Name: អ្នកប្រទេសទទួលប្រ UNITED SUNDSELLINE UNIOSON

swollog se ypod urunu ath to sissfirme would binn to guigemi prisourgeid :esu popusun

Clinical Application									Clinical Application
General
(Track I only)	Ophthalmic	Fetal Imaging
& Other	Cardiac	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Specify)	Other**
(Specify)		General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Specify)	Other**
(Specify)
Ophthalmic				Ophthalmic					Ophthalmic	Ophthalmic
		Fetal		Fetal					Fetal Imaging
& Other	Fetal
				Abdominal						Abdominal
				Intra-operative (Specify)		Pa	Pa	Pa		Intra-operative (Specify)	Pa
				Intra-operative (Neurosurgery)		Pa	Pa	Pa		Intra-operative (Neurosurgery)	Pa
				Laparoscopic	P		P	P		Laparoscopic	P
				Pediatric						Pediatric	P
				Small Organ (Specify)						Small Organ (Specify)	P
				Neonatal Cephalic						Neonatal Cephalic
				Adult Cephalic						Adult Cephalic
				Trans-rectal						Trans-rectal
				Trans-vaginal						Trans-vaginal
				TEE (non-cardiac)						TEE (non-cardiac)
				Trans-esoph. (non-Card.)						Trans-esoph. (non-Card.)
				Musculo-skel. (Convent.)						Musculo-skel. (Convent.)
				Musculo-skel. (Superfic.)						Musculo-skel. (Superfic.)
				Other: (Specify)						Other: (Specify)
				Other: Gynecological						Other: Gynecological
	Cardiac			Cardiac Adult					Cardiac	Cardiac Adult
				Cardiac Adult, TEE						Cardiac Adult, TEE
				Cardiac Neonatal						Cardiac Neonatal
				Cardiac Pediatric						Cardiac Pediatric
				Cardiac - Pediatric, TEE						Cardiac Pediatric, TEE
			Peripheral
Vessel	Peripheral Vascular						Peripheral
Vessel	Peripheral Vascular
				Other (spec.)						Other (spec.)

N = new indication. P = previously cleared by FDA in K122537 E added under Appendix 1 Specif

suoineriiseds - I xibuəddə nəbun bəbbi = 日 ΓΕΣΣΣΥλ ni ΑΠΑ για δεν είναι του = 9 ποιήκοιναι νωίτ = Ν

്തുകയും പ്രാമ്പ് മുന്നുമായ നാടാ 10 അവലംബം അവ

1 *

** 2 Includes: Molow, 8\Blow, Power flow

INCLUDES: MINNOW, DILION,
A.T.P., 10 SHRIMP

:squəmmo♡ İstinadlar Respublikasının Distrikçi Şahir Şahir Şahir Şahir Şahir Şahir Şahir Şah Şah Şah Şah Şah Şah Şah

Additional Comments

Additional Comments:

"s":"s","title":"

ə əsasə suranın pəsodxə səxnçının sura surasını səpnisu

structure (For example, ring structure) exposed during the organization of the supramolecular assembly.

current period (Ex4)
current period (Ex4)

EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) RUN DURATION (HR)

CONCENTRATED HYDROCHLORIC ACID (EXCESS)
NEUROTOXIN
CORROSIVE
IRRITANT

Excluding negligence, strict liability, and intentional torts, are there any other causes of action or theories of liability under which the defendant could be held liable for the injuries or damages alleged in the complaint?

EXCELLENT RESOLUTION (EXCELLENT PERFORMANCE)

(Excluding non-dairy processed cultures)

SCHIZOPHRENIA (EXCLUDING SCHIZOTYPAL DISORDER) 0

(รอมทุ่งออนด์ ์

Excluding Neurosurgery procedures)

SCHRODINGER PRODUCT

(Excluding Neurosurgery procedures).

Current strategies to address the opioid crisis:

Prevention:
- Education and awareness campaigns
- Prescription drug monitoring programs (PDMPs)
- Safe prescribing guidelines
- Early intervention programs
Treatment:
- Medication-assisted treatment (MAT)
- Behavioral therapies
- Detoxification programs
- Support groups
Harm Reduction:
- Naloxone distribution
- Syringe exchange programs
- Safe injection sites
- Drug checking services
Law Enforcement:
- Targeting drug traffickers
- Disrupting supply chains
- Investigating overdose deaths
- Holding prescribers accountable
Research:
- Understanding the neurobiology of addiction
- Developing new treatments
- Evaluating the effectiveness of interventions
- Identifying risk factors for opioid use disorder
Policy:
- Expanding access to treatment
- Reducing stigma associated with addiction
- Increasing funding for prevention and treatment programs
- Implementing harm reduction policies

Excluding neurosurgery procedures.

RELATIVE DOSE INTENSITY (PERCENT OF SCHEDULED DOSE)

broccoli sprouts

pressure (torque)

Excluding Dermatologic Surgery Procedures

Current Portfolio Strategy

Investment Objective: Long-term growth

Investment Strategy:

Equities: Invest in a diversified portfolio of stocks, focusing on companies with strong growth potential and a history of profitability.
Fixed Income: Invest in a mix of government and corporate bonds, with a focus on high-quality issuers.
Alternative Investments: Invest in a limited number of alternative investments, such as real estate and private equity, to enhance portfolio diversification and returns.

Asset Allocation:

Equities: 70%
Fixed Income: 20%
Alternative Investments: 10%

Risk Tolerance: Moderate

Time Horizon: Long-term (10+ years)

Introduction
Related Work
Proposed Approach
Experiments
Conclusion

20
Micrometers
(um) are
expanded
1000 times

INSTRUCTION MANUAL
MODEL: K-9000
ROBOT VACUUM CLEANER

ANALYTICAL METHOD

1% FORMIC ACID IN WATER
1% FORMIC ACID IN ACETONITRILE

COLUMN: WATERS BEH C18, 2.1 X 50MM, 1.7UM

FLOW RATE: 0.6 ML/MIN

GRADIENT: 5-95% B IN 1.5 MINUTES

SCANNING POSITIVE AND NEGATIVE MODE

RESOLUTION: 70,000 (FWHM)

SCAN RANGE: 100-1000 M/Z

INJECTION VOLUME: 1 UL

COLUMN TEMPERATURE: 40C

SAMPLE PREPARATION: DISSOLVED IN ACETONITRILE

(Excluding Neurosurgery Procedures)

includes virus and malware protection

excludes restoration (recovery) disc

(Excluding Tournament Proceeds)

EXCESSIVE DENTISTRY (RESTORATIONS)

INCREASED MARGINAL CARIES

(EXCLUDING NEUROSURGERY PROCEDURES)

(Excluding intercompany balances)

(Excluding neurosurgery procedures.)

(Exchanging, restructuring, procedures).

(Excluding Treasury Discount Procedures.)

(Excluding neurosurgery procedures)

(Excluding neurosurgery & procedures.)

(Excluding Neurosurgery Procedures)

(Excluding neurosurgery procedures)

(601.108 ЯНЭ IZ чэЧ) (quO эггү иолицийнэгэчЧ

A market and sentions no europies contribution in the most and

ก็ได้) เป็นโรงห์ โรวเรือไอไม่มีความที่ได้ งานี้เป็นที่ 10 อวริษัท บุคคลิว ใน ออกจากเวนตรี

offilian first of the scits only since and only of to actiff o ultlessionomics Resolucibles Health

(110-ugist noisivid)

(স)0। S

дээрээлээн тэмээр тэмээр хэвэг туургуулагтай хэрэгтэй тэгтэй тэгтэй туургуулагтай туургаан туургаан туургаан туургаан туургаан туургаан туургаан туургаар тууруулагаар тууруу

4

ISO FECU ROF SECOLT A SIGNI ANUOSA AT IU OIT SOME AID

: 1991 ps น ธ 1 T Device Name: អា-១៩១១-TSU UNITED SUNDSELLINE UNIOSON

swollof se ypod urunu ath to sissfisur would binn to guigemi prisourgeid :esu popusun

N = new indication. P = previously cleared by FDA in K122537 E added under Appendix 1 - Speci

suoinsairiseds - I xibuəddə nəbun bəbbi = H

്തുകയും പ്രാമ്പ് മുന്നുമായ നാടാ 10 അവലംബം അവ

1 *

** 2 Includes: Molow, 8\Blow, Power flow

Additional Commands:

:squəmmo♡ İstinadlar Respublikasının Distrikçi Şahir Şahir Şahir Şahir Şahir Şahir Şahir Şah Şah Şah Şah Şah Şah Şah

Additional Comments:

"s":"s","title":"

ə əsasə suranın pəsodxə səxnçının sura surasını səpnisu

Introduction

This document describes the process for exporting and importing data structures, including tables, views, and stored procedures, from one database to another using SQL Server Management Studio (SSMS). This process is useful for migrating databases, creating backups, or transferring specific database objects between environments.

Prerequisites

Before you begin, ensure you have the following:

SQL Server Management Studio (SSMS) installed.
Access to both the source and destination SQL Server instances.
Appropriate permissions to export and import database objects.

Exporting Data Structures

3.1. Connect to the Source Database

Open SQL Server Management Studio (SSMS).
Connect to the SQL Server instance containing the database you want to export from.
Expand the Databases node in Object Explorer.
Right-click on the database you want to export and select Tasks > Generate Scripts...

3.2. Configure Scripting Options

In the Generate and Publish Scripts wizard, click Next to bypass the Introduction page.
Choose Objects: Select the specific database objects you want to script (e.g., tables, views, stored procedures). You can choose to script the entire database or select specific objects.
Set Scripting Options: Click Next to configure the scripting options.
- General Options:
  - Script DDL ONLY: Set to True to script only the schema (structure) of the objects.
  - Script Data: Set to False to exclude data from the script.
  - Script DROP and CREATE: Set to Script DROP and CREATE to include DROP statements before CREATE statements in the script.
  - Script for Server Version: Choose the appropriate SQL Server version for compatibility.
  - Advanced Options: Click the Advanced button to configure additional options.
    - Types of data to script: Select Schema only.
    - Script Stored Procedures: Set to True if you want to script stored procedures.
    - Script Triggers: Set to True if you want to script triggers.
    - Script Indexes: Set to True if you want to script indexes.
    - Script Primary Keys: Set to True if you want to script primary keys.
    - Script Foreign Keys: Set to True if you want to script foreign keys.
    - Script Unique Keys: Set to True if you want to script unique keys.
    - Script Check Constraints: Set to True if you want to script check constraints.
    - Script Defaults: Set to True if you want to script defaults.
    - Script Rules: Set to True if you want to script rules.
    - Script User-Defined Data Types: Set to True if you want to script user-defined data types.
    - Script User-Defined Functions: Set to True if you want to script user-defined functions.
    - Script User-Defined Aggregate Functions: Set to True if you want to script user-defined aggregate functions.
    - Script User-Defined Table Types: Set to True if you want to script user-defined table types.
    - Script Full-Text Indexes: Set to True if you want to script full-text indexes.
    - Script Extended Properties: Set to True if you want to script extended properties.
    - Script Permissions: Set to True if you want to script permissions.
    - Script Logins: Set to True if you want to script logins.
    - Script Database Roles: Set to True if you want to script database roles.
    - Script Server Roles: Set to True if you want to script server roles.
    - Script Database Triggers: Set to True if you want to script database triggers.
    - Script Server Triggers: Set to True if you want to script server triggers.
    - Script Database Audit Specifications: Set to True if you want to script database audit specifications.
    - Script Server Audit Specifications: Set to True if you want to script server audit specifications.
    - Script Database Encryption Key: Set to True if you want to script database encryption key.
    - Script Server Encryption Key: Set to True if you want to script server encryption key.
    - Script Database Master Key: Set to True if you want to script database master key.
    - Script Server Master Key: Set to True if you want to script server master key.
    - Script Database Credentials: Set to True if you want to script database credentials.
    - Script Server Credentials: Set to True if you want to script server credentials.
    - Script Database Symmetric Keys: Set to True if you want to script database symmetric keys.
    - Script Server Symmetric Keys: Set to True if you want to script server symmetric keys.
    - Script Database Asymmetric Keys: Set to True if you want to script database asymmetric keys.
    - Script Server Asymmetric Keys: Set to True if you want to script server asymmetric keys.
    - Script Database Certificates: Set to True if you want to script database certificates.
    - Script Server Certificates: Set to True if you want to script server certificates.
    - Script Database XML Schema Collections: Set to True if you want to script database XML schema collections.
    - Script Server XML Schema Collections: Set to True if you want to script server XML schema collections.
    - Script Database Partition Functions: Set to True if you want to script database partition functions.
    - Script Server Partition Functions: Set to True if you want to script server partition functions.
    - Script Database Partition Schemes: Set to True if you want to script database partition schemes.
    - Script Server Partition Schemes: Set to True if you want to script server partition schemes.
    - Script Database Filegroups: Set to True if you want to script database filegroups.
    - Script Server Filegroups: Set to True if you want to script server filegroups.
    - Script Database Assemblies: Set to True if you want to script database assemblies.
    - Script Server Assemblies: Set to True if you want to script server assemblies.
    - Script Database User-Defined Types: Set to True if you want to script database user-defined types.
    - Script Server User-Defined Types: Set to True if you want to script server user-defined types.
    - Script Database User-Defined Functions: Set to True if you want to script database user-defined functions.
    - Script Server User-Defined Functions: Set to True if you want to script server user-defined functions.
    - Script Database User-Defined Aggregate Functions: Set to True if you want to script database user-defined aggregate functions.
    - Script Server User-Defined Aggregate Functions: Set to True if you want to script server user-defined aggregate functions.
    - Script Database User-Defined Table Types: Set to True if you want to script database user-defined table types.
    - Script Server User-Defined Table Types: Set to True if you want to script server user-defined table types.
    - Script Database Full-Text Catalogs: Set to True if you want to script database full-text catalogs.
    - Script Server Full-Text Catalogs: Set to True if you want to script server full-text catalogs.
    - Script Database Full-Text Stoplists: Set to True if you want to script database full-text stoplists.
    - Script Server Full-Text Stoplists: Set to True if you want to script server full-text stoplists.
    - Script Database Broker Priorities: Set to True if you want to script database broker priorities.
    - Script Server Broker Priorities: Set to True if you want to script server broker priorities.
    - Script Database Service Broker Endpoints: Set to True if you want to script database service broker endpoints.
    - Script Server Service Broker Endpoints: Set to True if you want to script server service broker endpoints.
    - Script Database Service Broker Queues: Set to True if you want to script database service broker queues.
    - Script Server Service Broker Queues: Set to True if you want to script server service broker queues.
    - Script Database Service Broker Services: Set to True if you want to script database service broker services.
    - Script Server Service Broker Services: Set to True if you want to script server service broker services.
    - Script Database Service Broker Routes: Set to True if you want to script database service broker routes.
    - Script Server Service Broker Routes: Set to True if you want to script server service broker routes.
    - Script Database Service Broker Contracts: Set to True if you want to script database service broker contracts.
    - Script Server Service Broker Contracts: Set to True if you want to script server service broker contracts.
    - Script Database Service Broker Message Types: Set to True if you want to script database service broker message types.
    - Script Server Service Broker Message Types: Set to True if you want to script server service broker message types.
    - Script Database Service Broker Remote Service Bindings: Set to True if you want to script database service broker remote service bindings.
    - Script Server Service Broker Remote Service Bindings: Set to True if you want to script server service broker remote service bindings.
    - Script Database Service Broker Event Notifications: Set to True if you want to script database service broker event notifications.
    - Script Server Service Broker Event Notifications: Set to True if you want to script server service broker event notifications.
    - Script Database Service Broker Activation Stored Procedures: Set to True if you want to script database service broker activation stored procedures.
    - Script Server Service Broker Activation Stored Procedures: Set to True if you want to script server service broker activation stored procedures.
    - Script Database Service Broker Target Initiator Authorizations: Set to True if you want to script database service broker target initiator authorizations.
    - Script Server Service Broker Target Initiator Authorizations: Set to True if you want to script server service broker target initiator authorizations.
    - Script Database Service Broker External Activator Endpoints: Set to True if you want to script database service broker external activator endpoints.
    - Script Server Service Broker External Activator Endpoints: Set to True if you want to script server service broker external activator endpoints.
    - Script Database Service Broker Queues Activation Stored Procedures: Set to True if you want to script database service broker queues activation stored procedures.
    - Script Server Service Broker Queues Activation Stored Procedures: Set to True if you want to script server service broker queues activation stored procedures.
    - Script Database Service Broker Queues Activation Service Broker Queues: Set to True if you want to script database service broker queues activation service broker queues.
    - Script Server Service Broker Queues Activation Service Broker Queues: Set to True if you want to script server service broker queues activation service broker queues.
    - Script Database Service Broker Queues Activation Service Broker Services: Set to True if you want to script database service broker queues activation service broker services.
    - Script Server Service Broker Queues Activation Service Broker Services: Set to True if you want to script server service broker queues activation service broker services.
    - Script Database Service Broker Queues Activation Service Broker Routes: Set to True if you want to script database service broker queues activation service broker routes.
    - Script Server Service Broker Queues Activation Service Broker Routes: Set to True if you want to script server service broker queues activation service broker routes.
    - Script Database Service Broker Queues Activation Service Broker Contracts: Set to True if you want to script database service broker queues activation service broker contracts.
    - Script Server Service Broker Queues Activation Service Broker Contracts: Set to True if you want to script server service broker queues activation service broker contracts.
    - Script Database Service Broker Queues Activation Service Broker Message Types: Set to True if you want to script database service broker queues activation service broker message types.
    - Script Server Service Broker Queues Activation Service Broker Message Types: Set to True if you want to script server service broker queues activation service broker message types.
    - Script Database Service Broker Queues Activation Service Broker Remote Service Bindings: Set to True if you want to script database service broker queues activation service broker remote service bindings.
    - Script Server Service Broker Queues Activation Service Broker Remote Service Bindings: Set to True if you want to script server service broker queues activation service broker remote service bindings.
    - Script Database Service Broker Queues Activation Service Broker Event Notifications: Set to True if you want to script database service broker queues activation service broker event notifications.
    - Script Server Service Broker Queues Activation Service Broker Event Notifications: Set to True if you want to script server service broker queues activation service broker event notifications.
    - Script Database Service Broker Queues Activation Service Broker Target Initiator Authorizations: Set to True if you want to script database service broker queues activation service broker target initiator authorizations.
    - Script Server Service Broker Queues Activation Service Broker Target Initiator Authorizations: Set to True if you want to script server service broker queues activation service broker target initiator authorizations.
    - Script Database Service Broker Queues Activation Service Broker External Activator Endpoints: Set to True if you want to script database service broker queues activation service broker external activator endpoints.
    - Script Server Service Broker Queues Activation Service Broker External Activator Endpoints: Set to True if you want to script server service broker queues activation service broker external activator endpoints.

3.3. Specify Output Options

Choose where to save the generated script. You can save it to a file, clipboard, or a new query window.
Click Next to review your selections.

3.4. Review and Generate Script

Review the summary of your selections.
Click Next to generate the script.
Once the script is generated, click Finish to close the wizard.

Importing Data Structures

4.1. Connect to the Destination Database

Open SQL Server Management Studio (SSMS).
Connect to the SQL Server instance where you want to import the database objects.
Open a new query window by clicking New Query.

4.2. Execute the Script

Open the generated script file in the query window.
Ensure the database context is set to the destination database by using the USE [YourDestinationDatabase] statement at the beginning of the script.
Execute the script by clicking Execute or pressing F5.

4.3. Verify the Imported Objects

After the script execution, refresh the Object Explorer.
Expand the Databases node and the destination database.
Verify that the tables, views, and stored procedures have been created successfully.

Troubleshooting

Syntax Errors: If you encounter syntax errors during script execution, review the script for any inconsistencies or compatibility issues with the destination SQL Server version.
Permissions: Ensure that the user executing the script has the necessary permissions to create objects in the destination database.
Dependencies: If there are dependencies between objects, ensure that the objects are created in the correct order to avoid errors.

Conclusion

By following these steps, you can successfully export and import data structures from one SQL Server database to another using SQL Server Management Studio. This process is essential for database migration, backup, and transferring database objects between different environments.

CHILDS-LANGMUIR EQUATION

Excluding non-recurring
items

Excluding neurosurgery procedures.

NEUROPATHIC PAIN (Excluding trigeminal neuralgia)

EXCLUDING NEURODEGENERATIVE PROCESSES).

PSEUDOMONAS AERUGINOSA (EXCLUDING PERITONEAL DIALYSIS ISOLATES)

(Excluding non-recurring revenue)

(Excluding neurodegenerative processes)

Excluding Neurosurgery Procedures)

Excluding
overlapping
periods

prostrate or decumbent, much-branched, glabrous or sparsely pubescent. Stems 10-40 cm long. Leaves: Petiole 0.5-2 mm long; blade linear to narrowly elliptic, 5-20 mm long, 1-3 mm wide, apex acute to obtuse. Inflorescences: Flowers solitary or in 2-3-flowered cymes; peduncle 0.5-2 mm long. Flowers: Sepals 5, lanceolate, 2-3 mm long, apex acute; petals 5, white, obovate, 3-5 mm long, 1.5-2.5 mm wide, apex rounded; stamens 10; styles 3. Capsules ovoid, 3-5 mm long, equaling or slightly exceeding sepals, 6-valved. Seeds brown, reniform, 0.5-0.8 mm long, papillate.

10
9
8
7
6
5
4
3
2
1
0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
Number of scattering events expected per image

What is your primary reason for using the Internet? (Ex: School, Work, Entertainment, etc.)
What type of Internet connection do you have at home? (Ex: Cable, DSL, Fiber, Satellite, etc.)
How many hours per day do you typically spend online? (Ex: 2-3 hours, 5+ hours, etc.)
What are your preferred online platforms or websites? (Ex: Social Media, Streaming Services, News Outlets, etc.)
How would you rate your overall satisfaction with your current Internet service provider? (Ex: Very Satisfied, Satisfied, Neutral, Dissatisfied, Very Dissatisfied)

proceedings of the
2011 winter simulation conference
paul hyden, navonil mustafee, michael rabe, periklis yannou, and jose padillo, eds.

Subject: [EXCI] Subject: New processing error

itoring strategies

Structure
and
expression
of
organizing

parameters
and
constraints

ctufES exposed auf
η της
igans and st
UrmSTO TO STITS TTTT sanргани
a
し
MOH)

.

ur camps prior to 10 am (Monday-Friday) or 11 am (Saturday-Sunday).

24
23
22
21
20
19
18
17
16
15
14
13
12
11
10
9
8
7
6
5
4
3
2
1
0

illiliters

includes imaging of organs and structures exposed during surgery.

Summary Results

Sample: 20230821-001

Analyte: Total Petroleum Hydrocarbons

Method: EPA 8015C

Labels	Values
Dilution	1
Result	Labels
-------------------------------	----------------------------------------------------------------------------------------------------
Task	Handling of powder products
Frequency	Daily
Duration	8 hours/day
Engineering Controls	Local exhaust ventilation
Personal Protective Equipment	Respirator (NIOSH-approved N95)
Exposure Monitoring Data	Air sampling results indicate an average respirable crystalline silica concentration of 0.04 mg/m³
Regulatory Limit	OSHA PEL: 0.05 mg/m³

Exposure Risk Characterization:

The measured exposure concentration of 0.04 mg/m³ is below the OSHA Permissible Exposure Limit (PEL) of 0.05 mg/m³. However, it is important to note that crystalline silica is a known carcinogen, and any exposure should be minimized to the extent feasible. The use of a respirator provides additional protection against inhalation exposure.

Recommendations:

Continue to use local exhaust ventilation during the handling of powder products.
Ensure that all employees wear a NIOSH-approved N95 respirator when handling powder products.
Conduct regular exposure monitoring to verify that exposure levels remain below the OSHA PEL.
Provide training to employees on the health hazards of crystalline silica and the proper use of engineering controls and personal protective equipment.
Consider implementing additional engineering controls to further reduce exposure levels, such as using a closed-loop system or a wet method.

Prepared by: [Your Name/Title]

Date: [Date]

APPROXIMATE PERCENTAGE OF TOTAL ENERGY EXPENDITURE

EXCLUDING NEUROLOGICAL PROCEDURES

(DEXAMETHASONE PHOSPHATE INJECTION, USP) (E)

MINIMALLY INVASIVE SURGERY COMPONENT
(Excluding Instrument Processing Fees)

MOTOR VEHICLE ACCIDENT REPORT
(EXCLUDING BICYCLES, PEDESTRIANS, ETC.)

Maximum String Length (Excluding Trailing Spaces)

$\beta$

Normalized Intensity (arb. units)

(Excluding neurosurgery procedures)

MASSIVE HAMMER WITH MAXIMUM POWER

(Excluding Recurrent Disconnects)

includes ligaments and structures exposed during removal of ovaries or uterus (E)

Excluding neurosurgery procedures (Dexmedetomidine)

(Excluding non-surgery procedures).

(Excluding neurosurgery procedures).

(EXCLUDE NEUROSTIMULATORY PROCEDURES)

(Excluding neurosurgery procedures.)

(รอมทุ่งออนด์ ์

(
Thousands of barrels
per day, excluding
condensate)

(Excluding re-invoicing procedures)

(Excluding neurosurgery procedures.)

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A manufacturers and summer of continuous in the most and

ก็ได้) เป็นโรงห์ โรวเรือไอไม่มีความที่ได้ งานี้เป็นที่ 10 อวริษัท บุคคลิว ใน ออกจากเวนตรี

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(স)0 I S

5

NAOFESU SOFISMOITASIONANIO SAATIU OITSOMOATO

swollot se ypod usund ath to sistems woll binfl 10 guigemi punoserthu orisourgeid ... Sur bebrein

Clinical Application
General
(Track I only)	Specific
(Tracks I & III)	B	M	PWD	CWD	Color
Doppler	Combined*
(Specify)	Other**
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify)					Pa	Pa	Pa
	Intra-operative (Neurosurgery)					Pa	Pa	Pa
	Laparoscopic	P	P	P	P	P	P	P
	Pediatric
	Small Organ (Specify)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
Cardiac	TEE (non-cardiac)
	Trans-esoph. (non-Card.)
	Musculo-skel. (Convent.)
	Musculo-skel. (Superfic.)
	Other: (Specify)
	Other: Gynecological
	Cardiac Adult
	Cardiac Adult, TEE
	Cardiac Neonatal
	Cardiac - Pediatric
	Cardiac - Pediatric, TEE
Peripheral
Vessel	Peripheral Vascular
	Other (spec.)

enoined] : 1 xipusddy : 1 xipusddy : 1 8052417 x 3 01041 x 1 x 101 x d 1 vd beares (renoverd = 1 ... inchsibui war = N

്തുകയും പ്രാമ്പ് മുന്നുമായ നാടാ 10 അവലംബം അവ

COVE SUNAVACOVE (CO/M (AWA/A (M/8 - abom Suitersego U269 10 uoitsuidung) I *

** 2 IIIclide: Moltow, B\B\bow, Power flow.

Includes: Mllow, Bllow, F
10%

:squəmmo♡ İstinadlar Respublikasının Distrikçi Şahir Şahir Şahir Şahir Şahir Şahir Şahir Şah Şah Şah Şah Şah Şah Şah

Additional Comments:

itional comments:

:"B" എന്നാടുന്നു. əsinə suranın pəsodxə səmçinin bura surasın 10 quişlemi səpnilər

script "a".

exposed during surge

Includes imaging of organs and structures exp

cript "a".
Includes imaging of organs and structures expose osed during surger

imaging of organs and structures exposed during surgery, including "open" and laparoscopic procedures.

cript "a":

xposed during surg

Includes imaging of organs and structures expos

transcript "included is. image during of organization and structure res exposed surgeons"

structures exposed during surgery include:

Imaging of organs and structures exposed during surgery includes "a" script.

imaging of organs and structures exposed during surgery includes "a" pt.

including structures exposed during organization and management.

DONOR'S NAME AND ADDRESS (Include apt. no., street, and city or town. If you are donating securities, see Form 8283, Section B.)

includes imaging of organs and structures exposed during "a" laparotomy.

script "a" includes imaging of organs and structures exposed during surgery.

including major organs and structures exposed during autopsy.

including structures and organs of the body exposed during surgery.

Represents samples that are exposed during sampling of structures, and includes information relating to number of organisms and their structures.

g
221

Imaging of organs
and structures
exposed during
surgery includes

Introduction

This document describes the data and structure of the National Cancer Institute (NCI) Thesaurus, a controlled vocabulary developed by NCI. The NCI Thesaurus is used for indexing and retrieval, data characterization, and application development. It covers a broad range of NCI-related terminology, including cancer-related diseases, findings, and concepts. It also includes terminology related to other biomedical areas, such as anatomy, drugs, and biological processes. The NCI Thesaurus is the source vocabulary for the NCI Metathesaurus and is harmonized with other biomedical vocabularies, such as SNOMED CT and UMLS. The NCI Thesaurus is available in OWL format and can be downloaded from the NCI website.

The NCI Thesaurus is a directed acyclic graph (DAG) of concepts. Each concept is represented by a unique code and has a set of properties, such as name, definition, and synonyms. The concepts are organized into a hierarchy, with broader concepts at the top and narrower concepts at the bottom. The NCI Thesaurus also includes relationships between concepts, such as "is a" and "part of".

The NCI Thesaurus is used by a variety of applications, including:

Indexing and retrieval of cancer-related information
Data characterization of cancer-related data
Application development for cancer-related applications

The NCI Thesaurus is a valuable resource for anyone working with cancer-related information.

HOURS MINIMUM OF 0.5 CONTINUOUS CARBON DIOXIDE EXPOSURE DURING SLEEPING HOURS INCLUDES IMAGINE SLEEPING NEXT TO A RUNNING CAR IN A CLOSED GARAGE.

Organized structure exposed

including the size and structure of organs and structures exposed during surgery.

inches
MAGNIFIED BORDER, MARKERS & NUMBERS 300 DPI

INTRODUCTION TO ORGANIC STRUCTURES

Bond-Line Formulas

Bond-line formulas are the standard way of drawing organic molecules. They are faster to draw and easier to read than other types of structural formulas. The following rules apply to bond-line formulas:

Carbon atoms are not usually shown. Instead, the end of a line represents a carbon atom, and a vertex (where two lines meet) represents a carbon atom.
Hydrogen atoms bonded to carbon are not shown. Each carbon atom is assumed to be bonded to enough hydrogen atoms to give it four bonds.
All atoms other than carbon and hydrogen are shown. Hydrogen atoms bonded to atoms other than carbon are also shown.
A line represents a bond. A single line represents a single bond, two lines represent a double bond, and three lines represent a triple bond.
The zig-zag pattern is used to represent single bonds. This is because the tetrahedral geometry of carbon atoms causes the bonds to be arranged in a zig-zag pattern.
Lone pairs are not usually shown. However, they may be shown if they are important for understanding the reactivity of the molecule.

Here are some examples of bond-line formulas:

Bond-line formulas

As you can see, bond-line formulas are a very efficient way of drawing organic molecules. They are also very easy to read, once you get used to them.

Functional Groups

A functional group is a specific group of atoms within a molecule that is responsible for a characteristic chemical behavior of that molecule. Functional groups are important because they allow us to predict the reactivity of a molecule based on its structure.

Here are some of the most common functional groups:

Alkane: A hydrocarbon containing only single bonds.
Alkene: A hydrocarbon containing at least one double bond.
Alkyne: A hydrocarbon containing at least one triple bond.
Alcohol: A compound containing a hydroxyl group (-OH).
Ether: A compound containing an oxygen atom bonded to two alkyl groups (R-O-R').
Aldehyde: A compound containing a carbonyl group (C=O) bonded to at least one hydrogen atom.
Ketone: A compound containing a carbonyl group (C=O) bonded to two alkyl groups (R-C=O-R').
Carboxylic acid: A compound containing a carboxyl group (-COOH).
Ester: A compound containing a carboxyl group (-COOR).
Amine: A compound containing a nitrogen atom bonded to one, two, or three alkyl groups (R-NH2, R2NH, R3N).
Amide: A compound containing a nitrogen atom bonded to a carbonyl group (R-CO-NH2).

These are just a few of the many functional groups that exist in organic chemistry. By learning to recognize these functional groups, you will be able to predict the reactivity of a wide variety of organic molecules.

CENTIMETERS & MILLIMETERS

IMAGING FINDINGS & CLINICAL SIGNIFICANCE
Imaging findings of congenital structural anomalies exposed during routine prenatal screening and diagnostic imaging.

INCREASING MAGNITUDE OF ORGANIC AND INORGANIC COMPONENTS AND STRUCTURES EXPOSED DURING 0.5 M NaOH TREATMENT

Source string magnitude (F)

includes imaging of organs and structures exposed during surgery.

Includes images of organs and structures exposed during dissection.

Includes imaging of organs and structures exposed during routine colonoscopy.

MAXIMUM ANNUAL DOSE TO MEMBER OF THE PUBLIC FROM NORMAL OPERATIONS (mrem/year)

includes, improves, and structures quality of datasets and public resources exposed during research.

• Includes imaging of organs and structures exposed during laparotomy (exploratory laparotomy, exploratory laparoscopy, or open abdominal approach)

Includes minerals & organic compounds that are exposed during weathering of rocks.

pasodxa sajmanjus pur Surajю о дшави sappia
sr
(Excluding neurosurgery procedures).

REVISED DOSAGES FOR PATIENTS CURRENTLY RECEIVING CARBOPLATIN AND PEMETREXED

Include measures to control symptoms of nausea and vomiting during chemotherapy.

COLORING, MOISTURIZING, AND
PROTECTING LIP GLOSS

PACIFICA COSMETICS INC. PORTLAND, OR 97204
MADE IN USA (WITH IMPORTED COMPONENTS)
PACIFICA BEAUTY.COM

Outer membrane porin structures
(Gram-negative bacteria)

Includes images of organs and structures exposed during dissection (Courtesy of Anatomy.tv, Primal Pictures)

GROUND BASED MEASUREMENTS OF COLUMN OZONE AND STRATOSPHERIC TEMPERATURES EXPOSED DURING THE 2023 ANTARCTIC OZONE HOLE (Extended Abstract)

Buinn pasodxa sองทาวทงUS DUR SUBOJю о бшавш sappiaur
(Excluding
ery pro
Hures)

nagodro go

(Excluding neurosurgery procedures).

του ηττη στητο το и дори

includes images of drains and structures exposed during demolition. (Composite: Includes asbestos building materials.)

includes images of organs and structures exposed during surgery.

Includes images of organs and structures exposed during abdominal dissection.

GROUND BEEF CONTAINS UP TO 10% ADDED SOLUTION OF ORGANIC BROTH AND ROSEMARY EXTRACT (INCLUDES INGREDIENTS TO ENHANCE FLAVOR AND TENDERNESS)

ANALYTIC SOLUTION FOR THE CONCENTRATION PROFILE DURING AQUEOUS PROCESSING OF A MULTICOMPONENT ALLOY (II. DIFFUSION-CONTROLLED DISSOLUTION)

(Excluding nursery processed components).

Excluding neurosurgery & radiotherapy procedures (minutes)

(Excl. respiratory droplets/aerosols)

itoring network surgery (EXCLUDING DEDUCTIBLE PORTIONS).

(səxnpəsond xəsərnən saunan suipnləxi])

(601.108 ЯНЭ IZ чэд) (quO ash uoi)diussan

A ma

นาโอ) นักโธอH ไลว่เรือไปเท่าหลี พรรม เร็ ซึ่งสามารถเป็น เป็นตอนตรีที่ 0 เหตุการะหน

ltlesH lesigoloibeA bus soitsongsio oniV ul to echilO dillesH โหวเรียดไงไม้มีความ 10 แบบเริ่มกับ

(110-ugi2 noisivi (1)

(ڊ)01 ڪ

да сарын тараа баратын тараат салатын тараат салатын тараат салатын таратын таратын таратын таратын таратын таратын таратын таратын таратын таратын таратын таратын таратын та

6

510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.

21 CFR 807.92, Subsection a

1. Submitter's Information:
Address:	Hitachi Aloka Medical America, Inc.
10 Fairfield Boulevard
Wallingford, CT 06492-5903
Contact:	Angela Van Arsdale
RA/QA Manager
Telephone:	(203) 269-5088 Ext: 346
Fax Number:	(203) 269-6075
Date Prepared:	July 28, 2015
2. Device / Common / Classification Name / Classification / Product Code:
Device Proprietary Name(s):	L43K
Manufacturer:	Hitachi, Ltd. Healthcare Tokyo Works
3-7-19 Imai,
Ome-Shi, Tokyo 198-8577 Japan
Common Name:	Diagnostic Ultrasound Transducer
Classification:	Class II
Product Code:	90-ITX 892.1570 Diagnostic Ultrasonic Transducer
Device Proprietary Name(s):	UST-5550-R;
UST-5536-R;
Manufactured in the U.S.A.
by:	MD MedTec, LLC.
14 Inverness Drive E, Suite F140
Englewood, Colorado 80112 U.S.A.
Manufactured for:	Hitachi, Ltd.
2-16-1, Higashi-Ueno, Taito-ku
TOKYO, 110-0015 JAPAN
Common Name:	Diagnostic Ultrasound Transducer
Classification:	Class II
Product Code:	90-ITX 892.1570 Diagnostic Ultrasonic Transducer
3. Legally Marketed Predicate Device(s):
	UST-5536-7.5 Intraoperative Ultrasound Transducer [K111227];
EUP-O54J Intraoperative Ultrasound Transducer [K142368]
4. Device Description:
	Linear Array transducer
5. Indication for Use:
	The UST-5550-R and UST-5536-R transducer is intended for use with the PROSOUND
ALPHA 7 Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for
the diagnostic ultrasound evaluation during robotic* and non-robotic** intra-operative and
laparoscopic procedures.
	The L43K transducer is intended for use with the ARIETTA60, ARIETTA70 and NOBLUS
Diagnostic Ultrasound Systems by trained personnel (doctor, sonography, etc.) for diagnostic
ultrasound evaluation during robotic* and non-robotic** intra-operative and laparoscopic
procedures.
	This device is not indicated for Ophthalmic applications.
	*For robotic use, these devices can only be used with the da Vinci™ Surgical System and da
Vinci™ 8 mm ProGrasp Forceps.
	**For non-robotic use, these devices can only be used with the Covidien SILS™ Clinch

7

21 CFR 807.92, Subsection a - Continued

6. Comparison to predicate device:

The UST-5550-R, UST-5536-R and L43K Intraoperative linear transducers are technically comparable and substantially equivalent to the currently marketed UST-5536-7.5 and EUP-054J. The difference between the subject devices (UST-5550-R, UST-5536-R & L43K) and predicate (UST-5536-7.5) is the material change to Titanium and dimensional/design changes to the probe head to include a linear ridge. The UST-5536-R have the same array dimension, number of elements and element spacing as the predicate UST-5536-7.5.

The subject devices UST-5550-R and UST-5536-R are manufactured in the U.S.A. by SOMA Manufacturing, LLC in accordance to specifications and components provided by the manufacturer: Hitachi Aloka Medical, Ltd. located in Tokyo, Japan.

The subject device L43K contains the same array diment and element spacing as the predicate EUP-O54J Intraoperative linear transducer with the same probe head design and material as the UST-5550-R.

The L43K is manufactured in its entirety by Hitachi, Ltd., Japan.

The subject and predicate transducers are compatible with track 3 diagnostic ultrasound systems and incorporate the same fundamental and scientific technologies. The only difference between the subject and predicate devices is a material change: along with minor dimensional and design modifications to probe head at the distal end of the subject devices. The material has been changed to Titanium and the scanning head is modified to add a small linear ridge to allow surgical graspers or robotic arm graspers to hold and control the scanning intraoperative or laparoscopic procedures. Neither the changes to the scanning head (dimensional and material) or the use of either surgical graspers or robotic arm graspers to manipulate the device change the intended use of the device.

The following compares the subject and predicate devices:

Subject devices:	Predicate devices:
Reusable device	Reusable device
New material: Titanium	All materials previously cleared by FDA
Intraoperative linear array	Intraoperative linear array
Modes of operation: B, M, PWD, CD, PowerFlow and	Modes of operation: B, M, PWD, CD, PowerFlow and
Combination of each operating mode	Combination of each operating mode

8

21 CFR Part 807.92, Section b

| 1. Non-clinical
Testing: | No new hazards were identified with the modification to the scanning head. The bend and
flexibility durability testing demonstrates that the material change to Titanium of the transducer
head shell and the "T' attaching mechanism design to all the option grasping the transducer head
by either a da Vinci 8mm ProGrasp grasping mechanism or Covidien SILS manual grasper
instruments for intra-operative or laparoscopic procedure scanning does not add any additional
risk nor effect image quality. | | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The following outlines the testing: | | |
| | Test | Acceptance Criteria | Result |
| | Grasp and Release Test with da
Vinci 8 mm ProGrasp robotic arm | Grasp and release with UST-5550-R
/L43K the 8mm ProGrasp robotic arm
starting straight, 180° and straight and
releasing 100/500 times. The L43K
must complete the testing without loss
of imaging performance or broken
and/or loose components. | Pass – after completing 100 and 500
grasp and release movements there is
no signs of physical damage and no
changes in imaging performance. |
| | Bend and Flexibility Test with da
Vinci 8 mm ProGrasp robotic arm | Bend and Release with UST-5550-R
/L43K with da Vinci S and Prograsp
8mm Forceps. All Robotic Ultrasound
Probe samples must complete
500/1000 random articulations in a
north, south, east and west direction
without loss of imaging performance,
broken and/or loose components. | Pass - after completing 500 and 1000
random articulations in a north, south,
east and west direction there were no
broken and/or loose components and
no loss of imaging performance. |
| 2. Clinical testing: | None required | | |
| 3. Conclusion: | The UST-5550-R, UST-5536-R and L43K Transducers is substantially equivalent in safety and
effectiveness to the predicate device(s);
The subject and predicate device(s) are both indicated for inter-operative diagnostic
ultrasound imaging. The subject and predicate device(s) have the same gray scale and doppler capabilities. The subject and predicate device(s) have the same essential technology for imaging, doppler
functions and signal processing. The subject and predicate device(s) have acoustic level below the Track 3 FDA limits. The subject and predicate device(s) are manufactured in accordance to FDA 21 CFR 820
Quality System Regulations. The subject and predicate device(s) are designed and manufactured to the same electrical and
physical safety standards. The subject and predicate device(s) are manufactured with materials that have been tested in
accordance to ISO 10993-1; all biocompatibility testing has been conducted in accordance to
each component material characterization, type of body contact, and duration contact risk
profile. The subject and predicate device(s) are supplied non-sterile with instructions for cleaning,
disinfection and sterilization in the transducer manuals. | | |
| | | | |

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 892.1570 Diagnostic ultrasonic transducer.

ISOF ECU SOF SMOITACIONI ANUOSAAT JU OITSOMDAIO

: 1991 ps น ธ 1 T Device Name: ​អ្នក​ប្រទេស​ទទួល​ប្រ UNITED SUNDSELLINE UNIOSON

Current Portfolio Strategy

ISO FECU ROF SECOLT A SIGNI ANUOSA AT IU OIT SOME AID

Summary Results

NAOFESU SOFISMOITASIONANIO SAATIU OITSOMOATO

g 221

INTRODUCTION TO ORGANIC STRUCTURES

510(k) Summary of Safety and Effectiveness in accordance with 21 CFR Part 807, Subpart E, Section 807.92.

6. Comparison to predicate device:

21 CFR Part 807.92, Section b

END OF SUMMARY

: 1991 ps น ธ 1 T Device Name: អ្នកប្រទេសទទួលប្រ UNITED SUNDSELLINE UNIOSON

g
221