The Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosurgical instrument indicated to be used in general laparoscopic and gynecologic procedures to allow high frequency monopolar cutting and coagulation. The reposable scissors are indicated to mechanically cut tissue and suture.

Device Description

The Snowden-Pencer™ Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosurgical instrument that is intended to produce a specific tissue effect such as dissecting, cutting, or coagulation by directing a variety of electrical high frequency currents through to a target tissue without causing damage to non-target tissue. The scissors are designed to fit through a 5 mm trocar and are intended to cut, dissect and coagulate tissue during general laparoscopic and gynecological procedures. The device can be used in either the electrified or non-electrified state. The device has a disposable shaft and scissors tip (scissors insert) and a reusable handle. The scissors are available in three lengths 24, 36 and 45 cm and three blade designs: curved metzenbaum, mini-metzenbaum and hook. The disposable scissors insert is provided sterile and is for single use only. The handle can be reused following cleaning and sterilization and is supplied non sterile.

AI/ML Overview

The provided text describes a 510(k) summary for the Snowden-Pencer™ Laparoscopic Ergonomic Reposable Scissors. This document focuses on demonstrating the substantial equivalence of the modified device to existing predicate devices, rather than detailing a study proving the device meets specific acceptance criteria in the sense of a clinical trial for a novel AI device.

However, I can extract the "acceptance criteria" from the performance tests conducted and the "reported device performance" from the testing conclusions for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standards/Tests/FDA Guidance)	Reported Device Performance (Testing Conclusions)
Electrosurgical Safety & Performance	IEC 60601-1, 60601-2, 60601-2-2, 60601-2-18	All three scissors tips designs passed the 1kVp High Frequency Test and the Mains Frequency Test.
Cut and Coagulation Performance	Bench top and design validation testing	All three scissors tip designs, as appropriate, successfully cut a variety of material (tissue, suture, and gastric band). Scissors successfully dissect during electrosurgical cutting and coagulation.
Biocompatibility	ISO 10993-1, 10993-5 and 10993-10	Scissors materials are toxicologically and chemically acceptable for the indicated use.
Cleaning and Sterilization Validations	ISO 11135, ISO 11138-1, ISO 11737-1, ISO 11737-2, ISO17664, ISO17665-1, TIR12, ST79, ST81	Validations confirmed a sterility assurance level of 10-6.

Regarding the other requested information, the document is for a medical device (surgical scissors) and not an AI device. Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory submission.

Here's an attempt to address the other points, noting their inapplicability where relevant:

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

Sample Size: Not explicitly stated in terms of a "test set" for performance metrics like cutting, coagulation, and electrosurgical safety. For biocompatibility and sterilization, the "sample size" would relate to the number of units tested, but this detail is not provided.
Data Provenance: The tests are described as "Bench top and design validation testing." This implies internal testing conducted by the manufacturer (CareFusion 2200 Inc., McGaw Park, IL, USA). The data is retrospective in the sense that it was generated prior to submission for regulatory clearance.

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

Not applicable. This is not an AI study requiring expert ground truth labeling. Performance tests for electrosurgical devices typically involve objective measurements against established standards rather than subjective expert assessment of outputs.

4. Adjudication method for the test set:

Not applicable. This is not an AI study involving human expert judgment. Performance is assessed against quantitative standards.

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:

Not applicable. This is not an AI device. No MRMC study was performed. The document explicitly states: "N/A - No clinical tests were conducted for this submission."

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

Not applicable. This is a physical medical device, not an algorithm. Benchtop tests are inherently "standalone" in the sense that they assess the device's inherent physical and electrical properties.

7. The type of ground truth used:

The "ground truth" for this device's performance tests would be established by:
- Objective measurement against engineering specifications (e.g., electrical rating, cutting force, coagulation effectiveness).
- Compliance with recognized international standards (IEC, ISO) for medical device safety and performance.
- Material properties and biological response based on standardized biocompatibility tests.
- Sterility Assurance Level (SAL) based on validated sterilization protocols.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set.

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

Not applicable. This is not an AI device that requires a training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for CareFusion. The logo consists of a circular icon with a stylized letter "C" inside, followed by the word "CareFusion" in a bold, sans-serif font. The icon is to the left of the text, and the overall design is simple and professional.

SEP 7 2012

510(k) SUMMARY

The following is a summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92.

SUBMITTER INFORMATION
Name	CareFusion 2200 Inc.
Address	1500 Waukegan Road, McGaw Park, IL 60085USA
Phone Number	847-473-7334
Fax Number	847-473-7790
Establishment Registration Number	1423507
Name of Contact Person	Kate Fuller
Date Prepared	June 22, 2012
NAME OF DEVICE
Trade or Proprietary Name	Snowden-Pencer™ Laparoscopic ErgonomicReposable Scissors
Common or Usual Name	Laparoscopic Scissors
Classification Name	Electrosurgical, Cutting & Coagulation andAccessories
Classification Panel	79
Regulation	878.4800
Product Code	GEI, HET
Legally marketed device(s) to whichequivalence is claimed	K030890 — Snowden-Pencer SwitchbladeScissorsK931340 — V. Mueller Laparoscopic Scissors
Reason for 510(k) submission	Modify the take-apart feature on the devicefrom a disposable scissors tip to a disposableshaft and scissors tip.

Device Description

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through a 5 mm trocar and are intended to cut, dissect and coagulate tissue during general laparoscopic and gynecological procedures. The device can be used in either the electrified or non-electrified state.

The device has a disposable shaft and scissors tip (scissors insert) and a reusable handle. The scissors are available in three lengths 24, 36 and 45 cm and three blade designs: curved metzenbaum, mini-metzenbaum and hook.

The disposable scissors insert is provided sterile and is for single use only. The handle can be reused following cleaning and sterilization and is supplied non sterile.

Indications for Use

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

		Switchblade Scissors	V. Mueller
Characteristic	Modified Device	K030890 (Predicate)	Laparoscopic ScissorsK931340 (Predicate)
Reposable Device	ReusableHandle/DisposableShaft and Scissors Tip	Reusable Handle andShaft/DisposableScissors Tip	Reusable Handle andShaft/DisposableScissors Tip
Insulation	MT5000 Polyolefin	PolyvinylideneFluoride (PVDF) Kynar	Ptfe Teflon
Blade Designs	Metz, Mini Metz,Hook	SAME	SAME
Electrical Rating	1kVp	0.5kVp	Not Specified
Sterilization – Handle	Pre-Vacuum Steam(Wrapped)	SAME	SAME
Sterilization – Tip	EtO	Same	Gamma

The modified single-use disposable scissors tips and shaft is identical in intended use, principle of operations, and energy type to both the Switchblade Scissors and the V. Mueller® Laparoscopic Scissors. These devices provide delivery of high frequency energy through a connection to a monopolar electrical generator with a universal high frequency monopolar electrosurgical cord.

The modified device, like the predicates, is intended to cut and coagulate and can be used in either an electrified or non electrified state. The modified product has the same basic scissors tip design and is comprised of medical grade stainless steel. The modified device works in the same manner as the predicates, is of similar lengths, and is designed to be used through a 5 mm trocar. The insulation of the modified device has been used in other currently marketed HF surgical devices and has been tested for safety and effectiveness when used with HF monopolar energy.

The modified design has a disposable scissors tip and shaft, simplifying the cleaning of the

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handle by designing the device so that both the tip and the shaft are disposed after a single use.

All materials used in the construction of the modified device have been tested for safety and effectiveness and are deemed to be substantially equivalent to the predicate devices.

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

Modified Device Toct Summani

Performance Test Summary – Modified Device
Characteristic	Standard/Test/FDA Guidance	Testing Conclusions
Electrosurgical Safety andPerformance Tests	IEC 60601-1, 60601-2, 60601-2-2, 60601-2-18	All three scissors tips designspassed the 1kVp HighFrequency Test and the MainsFrequency Test.
Cut and CoagulationPerformance Tests	Bench top and designvalidation testing	All three scissors tip designs, asappropriate, successfully cut avariety of material (tissue,suture, and gastric band).Scissors successfully dissectduring electrosurgical cuttingand coagulation.
Biocompatibility Tests	ISO 10993-1, 10993-5 and10993-10	Scissors materials aretoxicologically and chemicallyacceptable for the indicateduse.
Cleaning and SterilizationValidations	ISO 11135, ISO 11138-1, ISO11737-1, ISO 11737-2,ISO17664, ISO17665-1, TIR12,ST79, ST81	Validations confirmed a sterilityassurance level of 10-6.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL
EQUIVALENCE AND/OR CLINICAL INFORMATION
N/A - No clinical tests were conducted for this submission.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

SEP 7 2012

Carefusion 2200, Incorporated % Ms. Katherine M. Fuller Manager, Regulatory Affairs 1500 Waukegan Road McGaw Park, Illinois 60085

Re: K113407

Trade/Device Name: Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HET Dated: August 24, 2012 Received: August 27, 2012

Dear Ms. Fuller:

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

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Page 2 -- Ms. Kate Fuller

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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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1500 Waukegan Road McGaw Park, IL 600085 847-473-7334 tel.

carefusion.com

Image /page/5/Picture/2 description: The image shows the logo for CareFusion. The logo consists of a black circle with a white shield inside on the left, and the word "CareFusion" in black on the right. The shield inside the circle has a stylized design with a pointed top and curved sides.

510(k) Number: K113407

Device Name:

Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors

Indications for Use:

Prescription Use _X (Part 21 CFR 801 Subpart D) And/Or

Over the Counter Use_ (21 CFR 801 Subpart C)

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

Concurrance of CDRH, Office of Device Evaluation (ODE)

(Division Sign-C (Division Sign-On)
Division of Surgical, Orthopedic.
Division of Surgices Division of Startive Devices

510(k) Number K113407

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.