The Snowden-Pencer MicroLap 3mm Laparoscopic Instruments are indicated to be used in laparoscopic and other minimally invasive procedures for cutting, clamping, suturing and dissecting and to allow high frequency monopolar cutting and coagulation.

Device Description

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments consists of a handle and insert assembly. The insert assembly contains a shaft and end-effector (jaw pattern). There are several device models that encompass various lengths, diameters and jaw patterns based on the surgeon's needs.

AI/ML Overview

The provided document is a 510(k) summary for the Snowden-Pencer MicroLap 3mm Laparoscopic Instruments. This type of submission is for medical devices that demonstrate substantial equivalence to a legally marketed predicate device, and it typically relies on non-clinical performance data rather than extensive clinical studies as seen with AI/ML devices. Therefore, much of the information requested in your prompt (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance) is not applicable or not found in this document.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies that prove it meets those criteria based on the provided text.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria / Characteristic	Performance Results (Acceptance Criteria implicitly met if "PASS")
Instrument strength	PASS (Strength Tests)
Device must be reusable	PASS (Cleaning and Sterilization Tests)
Device must maintain pneumoperitoneum	PASS (Pneumoperitoneum Test)
Device to meet required electrosurgical safety standards	PASS (IEC 60601-1, IEC 60601-2, IEC 60601-2-2, IEC 60601-2-18)
Device is able to be cleaned and sterilized	PASS (AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ANSI AAMI ST81, ISO 11138, ISO 17664, ISO 17665)
Device materials are biocompatible	PASS (ISO 10993)

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: This document does not specify the sample sizes (i.e., number of instruments tested) for each of the non-clinical performance tests. It states "Results Summary," which typically means the overall outcome for the tested batch/type.
Data Provenance: Not specified, but these are typically lab-based, internal company tests conducted to industry standards. They are non-clinical and not derived from patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for non-clinical performance tests like instrument strength or sterilization efficacy is established by adherence to recognized industry standards (e.g., ISO, AAMI, IEC standards), not by expert consensus in the medical sense for diagnostic tasks. The "experts" would be the engineers and technicians performing and verifying the tests in accordance with these standards.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in diagnostic studies involving human interpretation or clinical outcomes. For performance tests of a physical device, the "adjudication" is the objective measurement against a defined standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a physical surgical instrument, not an AI/ML diagnostic tool. Therefore, an MRMC study is not relevant or performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a physical surgical instrument, not an algorithm. Standalone performance for an algorithm is not applicable.

7. The type of ground truth used:

The "ground truth" for these tests is defined by the specific parameters and pass/fail criteria outlined in the referenced national and international performance standards (e.g., IEC 60601 series for electrosurgical safety, ISO 10993 for biocompatibility, AAMI/ANSI standards for cleaning and sterilization). For example, a "strength test" would have a defined force it must withstand without breaking or deforming.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical medical device like a laparoscopic instrument. (This term is relevant for AI/ML algorithms).

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary

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

May 4, 2017

CareFusion 2200 Inc. Ms. Jane Weber Regulatory Affairs Manager 75 North Fairway Drive Vernon Hills, Illinois 60061

Re: K163615

Trade/Device Name: Snowden-Pencer MicroLap 3mm Laparoscopic Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 28, 2017 Received: May 2, 2017

Dear Ms.Weber:

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 of medical devicerelated 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.

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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/ResourcesforYou/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, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K163615

Device Name

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

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

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510(k) SUMMARY – K163615

A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

SUBMITTER INFORMATION
Name	CareFusion 2200 Inc.
Address	75 North Fairway DriveVernon Hills, IL 60061
Phone number	(847) 362-8094
Fax number	(312) 949-0272
Establishment RegistrationNumber	1423507
Name of contact person	Jane Weber
Date prepared	28-APR-2016
DEVICE INFORMATION
Trade or proprietary name	Snowden-Pencer MicroLap 3mm Laparoscopic Instruments
Common or usual name	Reusable Laparoscopic Instruments
Classification name	Electrosurgical Cutting and Coagulation and Accessories
Classification panel	79 General and Plastic Surgery
Regulation	Class II per 21CFR 878.4400, Product code GEI
Product Code(s)	Multiple devices
Legally marketed device(s) towhich equivalence is claimed	BEMA Endoscopic Monopolar Instruments and Accessories -K102921, GEI
Reason for 510(k) submission	Launch new 3mm product line
Device description	Snowden-Pencer MicroLap 3mm Laparoscopic Instrumentsconsists of a handle and insert assembly. The insert assemblycontains a shaft and end-effector (jaw pattern). There are severaldevice models that encompass various lengths, diameters and jawpatterns based on the surgeon's needs.
Intended use of the device	To be used in laparoscopic and other minimally invasiveprocedures
Indications for use	The Snowden-Pencer MicroLap 3mm Laparoscopic Instrumentsare indicated to be used in laparoscopic and other minimallyinvasive procedures for cutting, clamping, grasping, suturing anddissecting and to allow high frequency monopolar cutting andcoagulation.

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

COMPARED TO THE PREDICATE DEVICE
Characteristic	Predicate Device	New Device
Type of Device	Reusable	Reusable
Intended for direct patientcontact?	Yes	Yes
Intended for extendeduse? (more than 24 hrs)	No	No
Active component	Monopolar	Monopolar
Length	18cm, 21cm, 33cm	24cm and 36cm
Diameter	3mm	3mm
Overall device design	Two-Piece Modular System	Two-Piece Modular System
Handle design	Ring and In-Line	Ring, Pistol-Grip and In-Line
Insert Assembly EndEffectors (jaw patterns)	ScissorsGraspersDissectorsNeedle Holders	ScissorsClampsGraspersDissectorsNeedle Holders
Rated Voltage	2 kVp in cutting/coagulation3 kVp in spray	1.5 kVp in all modes
Materials	Stainless Steel (SS)Raydel (Poylphenlsufone – PPSU)Tungsten CarbideSilver Braze3M DP490Halar SNylon	Stainless SteelRadel (Poylphenlsufone – PPSU)Tungsten CarbideSilver braze3M DP490Marabu Tampapur TPU 970 –WhiteLoctiteSantopreneEPDM RubberKraton
How Supplied	Non-Sterile	Non-Sterile
Sterilization Modalities	Pre-vacuum Steam	Pre-Vacuum Steam

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PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Performance Test Summary - New Device

Characteristic	Standard / Test / FDA Guidance	Results Summary
Instrument strength	Strength Tests	PASS
Device must be reusable	Cleaning and Sterilization Tests	PASS
Device must maintainpneumoperitoneum	Pneumoperitoneum Test	PASS
Device to meet requiredelectrosurgical safety standards	IEC 60601-1, IEC 60601-2, IEC 60601-2-2,IEC 60601-2-18	PASS
Device is able to be cleaned andsterilized	AAMI TIR12, AAMI TIR30, ANSI AAMIST79, ANSI AAMI ST81, ISO 11138, ISO17664, ISO 17665	PASS
Device materials arebiocompatible	ISO 10993	PASS

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

N/A - No clinical tests were conducted for this submission.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The results of the non-clinical tests demonstrate the Snowden-Pencer MicroLap 3mm Laparoscopic Instruments meet all performance requirements, and are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.