K Number

Device Name

INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM

Manufacturer

SUMMIT MEDICAL, INC.

Date Cleared

2014-12-15

(189 days)

Product Code

KCT

Regulation Number

880.6850

Intended Use

Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider. Instrument Protection System cassettes are intended to allow sterilization of the enclosed medical devices during a Sterrad® 100NX Express Cycle. The Instru-Safe Instrument Protection System cassettes are intended to be used in conjunction with a legally marketed wrap. The Instru-Safe Instrument Protection System cassettes are not intended on their own to maintain sterility. The Instru-Safe Instrument Protection System has no lumen claims for the Sterrad 100NX Express Cycle.

Device Description

Instru-Safe® Instrument Protection System cassettes are used to organize and protect other medical devices that are sterilized by a healthcare provider.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical device for organizing and protecting instruments during sterilization, with no mention of software, data processing, or AI/ML terms.

Therapeutic

No
The device is described as an "Instrument Protection System" used to organize and protect other medical devices during sterilization, not to provide therapy itself.

Diagnostic

Explanation: The device, Instru-Safe® Instrument Protection System cassettes, is used to organize and protect other medical devices during sterilization. Its function is to facilitate sterilization and maintain organization, not to diagnose medical conditions or provide diagnostic information.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical "Instrument Protection System cassettes" used to organize and protect other medical devices, indicating it is a hardware device.

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 that the device is used to organize and protect other medical devices during sterilization. It facilitates the sterilization process and maintains organization, but it does not perform any diagnostic testing on biological samples.
Device Description: The description reinforces the intended use of organizing and protecting other medical devices.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays for diagnostic purposes

The device is a sterilization accessory, not a diagnostic tool.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

KCT

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare provider

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)

Not Found

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing to the right, layered on top of each other. The profiles are connected by a flowing line that forms a wing-like shape above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.

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

December 15, 2014

Summit Medical Inc. Nicole Dove QA/RA Manager 815 Northwest Pkwy, Suite 100 St. Paul, MN 55121

Re: K141513

Trade/Device Name: Instru-Safe® Instrument Protection System Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Tray Regulatory Class: II Product Code: KCT Dated: October 24, 2014 Received: October 30, 2014

Dear Mrs. Nicole Dove:

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.

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" (21CFR 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/2/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a stylized font, with the word "medical" in a smaller font underneath. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.

Indications for Use Statement

Page of

510(k) number: K141513

Device Name: Instru-Safe® Instrument Protection System

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

Over-The-Counter X

Image /page/3/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a large, sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The overall design is simple and modern.

Indications for Use Statement

Page Page of

The worst case validated load by vent-to-volume calculation is the IN-2681 tray. The worst case validated load by number of instruments and estimated weight is the IN-8823-CF tray.

Image /page/4/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a sans-serif font, with the word "medical" in a smaller font below it. Above the word "SUMMIT" are three blue diamonds arranged horizontally. The logo is simple and modern, and the blue color gives it a professional look.

Indications for Use Statement

Part Number	Maximum # of Instruments	Estimated Weight - Tray w/ instruments (lbs)
IN-2681	13	0.64
IN-2682	13	0.89
IN-2683	13	1.39
IN-2840	36	8.75
IN-2842	24	6.5
IN-2843	36	8.75
IN-2880	56	12.1
IN-2900	22	4.18
IN-2950	12	4.1
IN-3030	34	9.5
IN-4000	20	3.2
IN-4003	30	3.25
IN-4010	10	1.98
IN-5401	6	2
IN-5401-02	2	1
IN-5401-03	2	1
IN-5401-08	8	3.2
IN-5401-12	12	3.25
IN-6103	2	2.15
IN-6105	2	2.15
IN-6110	3	2.15
IN-6203	2	2.75
IN-6205	2	2.75
IN-6210	2	2.75
IN-6240	2	2.75
IN-6303	2	3.28
IN-6305	2	3.28
IN-6310	2	3.28
IN-6403	2	3.28
IN-6405	2	3.28
IN-6410	2	3.28
IN-7012	1	1.07
IN-7032	2	1.1
IN-7150	8	1.9
IN-7223	10	9.2
IN-7224	15	7.2
IN-7225	10	9.5
IN-7723	15	7.18
IN-7724	15	7.2
IN-7725	10	9.5
IN-7823	25	4
IN-7940	20	13.25
IN-8240	20	13.5
IN-8420	20	13.5
IN-8610	2	6.65
IN-8612	2	6.8
IN-8613	2	6.1
IN-8615	2	5.8
IN-8616	2	5.8
IN-8620	3	7.2
IN-8621	4	7.18
IN-8622	4	7.18
IN-8630	3	6.5
IN-8632	3	6.45
IN-8633	3	6.8
IN-8640	4	5.35
IN-8642	4	5.35
IN-8643	5	5.35
IN-8645	4	5.35
IN-8660	4	5.35
IN-8662	4	5.35
IN-8663	4	5.35
IN-8810	20	13.5
IN-8820	15	8.75
IN-8823	45	14
IN-8830	15	8.75
IN-8833	45	14
IN-8840	20	13.75
IN-8850	15	8.75
IN-8853	45	14
IN-8860	15	8.75
IN-8862	30	10.5
IN-8863	45	14
IN-8880	2	3.28
IN-8882	16	12.1
IN-8883	2	3.28
IN-8884	4	5.35
IN-8885	1	2.25
IN-8886	6	12.1
IN-8889	6	12.1
IN-8891-S	1	2
IN-8891-SI-12-S	1	2
IN-8891-SI-85-S	1	2
IN-8892-01	12	12.1
IN-8893	9	7.5
IN-8894	5	16.1
IN-8897	8	6
IN-8898	10	10.25
IN-8899	7	6.5
IN-8901	1	2.25
IN-8902	22	17
IN-8903	15	13.25
IN-8904	22	17
IN-8907	7	12.5
IN-8945	2	5.18
IN-8946	9	6.1
IN-8980-01	20	9.5
IN-8982-01	17	9.5
IN-8983-01	16	9.5
IN-8984-01	15	9.5
IN-8986-S	2	6.5
IN-8987-S	2	6.5
IN-8988-S	2	6
IN-8989-S	2	6
IN-9999-160	6	12.1
IN-9999-162-S	2	5.8
IN-9999-168-S	2	5.8
IN-9999-172-S	2	5.8
IN-9999-178-S	2	5.8

Image /page/5/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in large, bold, blue letters, with the word "medical" in smaller, red letters underneath. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The logo is simple and modern, and the use of blue and red gives it a professional look.

Image /page/6/Picture/0 description: The image shows the logo for Summit Medical. The logo consists of the word "SUMMIT" in a bold, sans-serif font, with the word "medical" in a smaller, sans-serif font below it. Above the word "SUMMIT" are three blue diamonds, arranged horizontally. The overall design is clean and modern.