Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments are designed to transmit cutting, clamping, grasping, suturing and dissecting force to working tips in minimally invasive surgeries such as plastic and general laparoscopic procedures.

Device Description

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments consists of a handle, shaft and insert. The insert contains an 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments:

Based on the provided 510(k) Summary (K151036), this document describes a medical device modification (design change from single-piece to take-apart) rather than an AI/algorithm-based product. Therefore, many of the requested points related to AI/algorithm studies (like human-in-the-loop performance, training sets, etc.) are not applicable to this submission.

The acceptance criteria and supporting study are focused on ensuring the modified physical device maintains its safety and effectiveness compared to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standard / Test / FDA Guidance)	Reported Device Performance
Instrument strength (resistance to breakage/flexing)	Strength Tests	PASS
Inadvertent disassembly (during use)	Pull Strength Test	PASS
Ease of disassembly/reassembly (user convenience)	Force Tests	PASS
Handle reusability	Reliability Test	PASS
Handle compatibility with existing shafts and inserts	Handle ability to connect to worst case shafts and inserts	PASS
Device cleanability and sterilizability	AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ANSI AAMI ST81, ISO 11138, ISO 17664, ISO 17665	PASS
Biocompatibility of device materials	ISO 10993	PASS

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the exact sample sizes (e.g., number of instruments tested) for each non-clinical performance test. It only states that the tests were conducted and the device "PASSED" the criteria.

Data provenance: Not explicitly stated, but these are typically retrospective non-clinical engineering and laboratory tests conducted by the manufacturer, CareFusion 2200 Inc. The country of origin of the data would likely be the location where CareFusion performs its product testing, which can be global, but typically for FDA submissions, the testing adheres to international (ISO) and US (AAMI, ANSI) standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This question is not applicable. The "ground truth" for physical device performance tests like strength, pull, force, reliability, cleaning validation, and biocompatibility is established by engineering specifications, recognized national and international standards (e.g., AAMI, ANSI, ISO), and regulatory requirements, not by expert medical opinion in the same way an AI model's diagnostic accuracy might be judged. These tests are objective measurements against defined thresholds.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's ambiguity in classifying clinical data for ground truth establishment. For the objective non-clinical performance tests mentioned, the results are typically quantitative measurements that either meet or fail pre-defined acceptance limits based on standards and engineering requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "N/A - No clinical tests were conducted for this submission." MRMC studies are typically for evaluating diagnostic accuracy or clinical effectiveness, often involving human readers and AI assistance, neither of which is present in this submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study (referring to an algorithm's performance) was not done. This submission is for a physical surgical instrument, not an AI or algorithm-based device.

7. Type of Ground Truth Used

The "ground truth" for the performance tests undertaken are:

Engineering Specifications and Design Requirements: For parameters like instrument strength, inadvertent disassembly, ease of disassembly/reassembly, handle reusability, and handle compatibility. These are defined by the manufacturer based on expected operational loads and user interaction.
National and International Standards: For aspects like cleanability and sterilizability (e.g., AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ANSI AAMI ST81, ISO 11138, ISO 17664, ISO 17665) and biocompatibility (ISO 10993). These standards provide objective criteria and methodologies for testing.

8. Sample Size for the Training Set

This question is not applicable. There is no AI/algorithm, so there is no training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no AI/algorithm and thus no training set.

Summary

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

February 1, 2016

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

Re: K151036

Trade/Device Name: Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: December 14, 2015 Received: December 15, 2015

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/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.

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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Indications for Use

510(k) Number (if known) K151036

Device Name

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X 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)

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510(k) SUMMARY – K151036

Image /page/4/Picture/1 description: The image shows the CareFusion logo. The logo features an orange circle with a white shield inside, with a yellow accent on the top left of the shield. To the right of the circle is the text "CareFusion" in a gray sans-serif font. Below the text is the phrase "has joined BD" in a smaller, lighter gray font.

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

SUBMITTER INFORMATION
Name	CareFusion 2200 Inc
Address	75 N. Fairway Dr.Vernon Hills, IL 60061
Phone number	(847) 362-8094 (Jane Weber)
Fax number	(312) 949-0272 (Jane Weber)
EstablishmentRegistration Number	1423507
Name of contact person	Jane Weber, MS, Regulatory Affairs Managerjane.weber@carefusion.com
Date prepared	27-JAN-2016
DEVICE INFORMATION
Trade or proprietaryname	Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-GripLaparoscopic Instruments
Common or usual name	Reusable Laparoscopic Instruments
Classification name	Endoscopic and Accessories
Classification panel	78 Gastroenterology and Urology
Regulation	Class II per 21CFR 876.1500, Product code GCJ
Product Code(s)	Multiple devices
Legally marketeddevice(s) to whichequivalence is claimed	Snowden-Pencer Inc. - Reusable Laparoscopic Instruments - K930667,GCJ
Reason for 510(k)submission	Design modification to allow device to be taken apart
Device description	Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-GripLaparoscopic Instruments consists of a handle, shaft and insert. Theinsert contains an end-effector (jaw pattern). There are several devicemodels that encompass various lengths, diameters and jaw patternsbased on the surgeon's needs.
Intended use of thedevice	Cutting, clamping, grasping, suturing and dissecting
Indications for use	Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-GripLaparoscopic Instruments are designed to transmit cutting, clamping,grasping, suturing and dissecting force to working tips in minimallyinvasive surgeries such as plastic and general laparoscopic procedures.

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510(k) SUMMARY – K151036

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE 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
Cleaning Method	Manual and Automatic	Manual and Automatic
Sterilization Method	Product is sold non-sterile andsterilized by the end user via thefollowing steam sterilization options:• Gravity Displacement• Prevacuum	Product is sold non-sterile andsterilized by the end user viathe following steam sterilizationoptions:• Prevacuum
Materials	Stainless SteelAluminumRadel-RHalarTungsten Carbide	Stainless SteelRadel-RHalarTungsten Carbide
Handle Configuration	Ring Handle, In-Line handle, and Pistol Grip (bent)	In-Line handle and Pistol Grip(bent)
Shaft/End EffectorRotation Capability	Rotatable and Non Rotatable	Rotatable and Non Rotatable
Instrument Length	24cm, 33cm, 36cm, 45cm	24cm, 33cm, 36cm, 45cm
Instrument Diameter	3.5mm, 5mm, 10mm	5mm and 10mm
End Effectors (JawPatterns)	Scissors, Graspers, Dissectors,Clamps and Needle Holders	Scissors, Graspers, Dissectors,Clamps and Needle Holders
Device Configuration	Single-piece design	Take-Apart design

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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
Inadvertent disassembly	Pull Strength Test	PASS
Ease of disassembly/reassembly	Force Tests	PASS
Handle must be reusable	Reliability Test	PASS
Handle compatibility with existingshafts and inserts	Handle ability to connect to worst caseshafts and inserts	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 OFSUBSTANTIAL 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 Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments meet all performance requirements, and are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.