Integra™ Jarit® Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecologic surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon. For those instruments with electrosurgical capability, current can be used for coagulation and/or cutting as determined necessary and appropriate by the surgeon.

Device Description

Integra™ Jarit® Take-Apart Endoscopic Instruments easily separate into three components - insert, shaft, and handle. Inserts include graspers, dissectors, scissors, biopsy forceps and specialized spoon forceps. Inserts connect to either a 5mm or 10mm diameter shaft with lengths of 350mm or 425mm; inserts and shaft connect to monopolar handles which are available with/without rotation or ratchets. The reusable devices are packaged non-sterile and are steam sterilizable.

AI/ML Overview

The provided text describes the Integra™ Jarit® Take-Apart Endoscopic Instruments and summarizes performance data to demonstrate substantial equivalence to predicate devices, rather than a study testing against specific acceptance criteria for a new AI/software device. The information requested (multi-reader multi-case study, standalone performance, ground truth establishment for training, etc.) is typically associated with AI/ML-driven medical devices, which this submission is not.

Therefore, the response below is based on the performance testing reported for this physical medical device (endoscopic instruments) and will interpret "acceptance criteria" as meeting the "Pass" result for each test performed.

1. Table of Acceptance Criteria and Reported Device Performance

Testing Performed	Acceptance Criteria	Reported Device Performance
Manual Cleaning Validation (Spore Log Reduction) per AAMI TIR30:2003.	"Pass" (specific reduction not provided)	Pass
Mechanical Cleaning Validation (Spore Log Reduction) per AAMI TIR30:2003.	"Pass" (specific reduction not provided)	Pass
Manual Cleaning Validation (Protein Analyses) per AAMI TIR30:2003.	"Pass" (specific protein level not provided)	Pass
Mechanical Cleaning Validation (Protein Analyses) per AAMI TIR30:2003.	"Pass" (specific protein level not provided)	Pass
Pre-Vacuum (wrapped) Steam Sterilization Validation per ISO at 132°C with an Exposure Time of 4 minutes and a Minimum Drying Time of 20 minutes.	"Pass" (sterility assurance level not provided)	Pass
Biocompatibility Testing for both PEEK and PPSU materials according to ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation & Sensitization)	"Pass" (specific criteria from ISO standards applied)	Pass
Electromagnetic Compatibility & Safety Testing per IEC-60601-2-2:09.2007 according to manufacture's rated voltage 3,000 VB and tested frequency of 450 kHz.	"Pass" (specific criteria from IEC standard applied)	Pass
Load validation of intended use during surgery.	"Pass" (specific criteria not provided)	Pass
Mechanical Endurance Test	"Pass" (specific criteria not provided)	Pass
Reprocessing Test - 100 Autoclave Cycles per DIN EN 285 at 134°C with an exposure time of 5 minutes.	"Pass" (specific criteria from DIN EN standard applied)	Pass
Corrosion Resistance Testing for all Metal parts according to Boiling Test DIN EN ISO 13402.	"Pass" (specific criteria from DIN/ISO standard applied)	Pass

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

The document does not specify the exact sample sizes (e.g., number of instruments, number of cycles) for each validation or test. The testing appears to be conducted in a laboratory setting to demonstrate compliance with various standards (e.g., AAMI, ISO, IEC, DIN EN) for reprocessing, biocompatibility, electrical safety, and mechanical endurance. The data provenance is not explicitly stated as retrospective or prospective in the context of clinical studies but rather as laboratory testing results. The country of origin of the data is not specified beyond the manufacturer being Integra York PA, Inc., USA.

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

This information is typically relevant for studies involving human interpretation or subjective assessment with expert consensus. For the described validation and performance tests of a physical medical device (endoscopic instruments), "ground truth" is established by adherence to recognized international technical standards and laboratory testing protocols. The document does not specify human experts for establishing "ground truth" in this context.

4. Adjudication method for the test set

Not applicable. This concept (e.g. 2+1, 3+1) is typically used for clinical review of medical images or data where human experts review and adjudicate discrepancies, commonly found in AI/ML performance studies. Here, performance is evaluated against defined technical standards and test methods.

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 a premarket notification (510(k)) for a physical medical device (endoscopic instruments), not an AI/ML-driven software device. Therefore, no MRMC study or AI assistance evaluation was performed or is mentioned.

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

Not applicable, as this device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used

For the various performance tests (cleaning, sterilization, biocompatibility, electrical safety, mechanical endurance, corrosion resistance), the "ground truth" is defined by the specific, objective criteria outlined within the cited national and international standards (e.g., AAMI TIR30:2003, ISO 10993, IEC-60601-2-2, DIN EN 285, DIN EN ISO 13402). For example, for sterilization, the ground truth would be achieving a specified Sterility Assurance Level (SAL), and for cleaning, a specified reduction in microbial load or protein residue, as per the standard. There is no mention of expert consensus, pathology, or outcomes data as a primary ground truth in this context.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device. Therefore, there is no "training set."

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant to the provided submission.

Summary

{0}------------------------------------------------

K103726

FEB - 8 2012

Image /page/0/Picture/2 description: The image shows the logo for Integra. The logo has the word "INTEGRA" in all caps on the top line. Underneath that, in smaller letters, is the phrase "LIMIT UNCERTAINTY". To the right of the text is a graphic of several black squares of different sizes stacked on top of each other.

589 Davies Drive
York, Pa 17402
Phone (717) 940-8335
Toll Free (800) 221-1344
Fax (717) 840-9347
www. Integralife.com

510(k) Summary

Submitted by:	Integra York PA, Inc.589 Davies Drive, York, PA 17402 USA
Contact Person:	Stephanie Sheesley, Regulatory Affairs ManagerIntegra York PA, Inc.589 Davies Drive, York, PA 17402 USAPhone: (717) 717-840-2774 Fax: (717) 840-3509
Date Prepared:	January 31, 2012
Device Trade Name:	Integra™ Jarit® Take-Apart Endoscopic Instruments
Device Common Name:	Endoscopic Instruments
Classification Name:	Coagulator-Cutter, Endoscopic, Unipolar (and Accessories)
Device Class:	Class II
Product Code:	KNF
CFR Classification:	21 CFR 884.4160
Subsequent Product Code:	GEI
Subsequent CFR Classif.:	21 CFR 878.4400

Device Description:

Indications For Use:

CONFIDENTIAL

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Integra. The logo consists of the word "INTEGRA" in a sans-serif font, with the tagline "LIMIT UNCERTAINTY" underneath. To the right of the word "INTEGRA" are several squares of varying sizes, arranged in a descending order.

589 Davies Drive
York, Pa 17402
Phone (717) 940-8335
Toll Free (800) 221-1344
Fax (717) 840-9347
www. Integralife.com

Predicate Devices:

510(k) #	Device	Manufacturer	Product Code
K932456	Jarit Surgical Instruments	Integra York PA, Inc.	KNF
K010752	Aesculap Modular Endo. Instr.	Aesculap, Inc.	KNF
K103282	Laparoscopic Dissector	Applied Medical Resources	GEI
K962119	Re-New Laparoscopic Instr,	Microline Surgical, Inc.	GEI
K043013	Miltex Laparoscopic Instr.	Miltex, Inc.	HET

Refer to attached predicate comparison charts 5-1A and 5-1B

Performance Standards:

No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices. However, the Integra™ Jarit® Take-Apart Endoscopic Instruments conform to the following standards:

· IEC-60601-2-2: Medical electrical equipment Part 2-2: Particular requirements for the safety of high frequency surgical equipment
ANSI/AAMI ST79:2006/A2:2009: Steam Sterilization and Sterility . Assurance in Health Care Facilities
ANSI/AAMI ST77:2006: Containment Devices for Reusable Medical . Devices Sterilization
. ANSI/AAMI ST8:2008: Hospital Steam Sterilizers
AAMI TIR12:2004: Designing, Testing, and Labeling Reusable Medical . Devices for Reprocessing in Health Care Facilities. A Guide for Device Manufacturers
AAMI TIR30:2003: A Compendium of Processes, Materials, Test . Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices
. AAMI ST81:2004: Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
. EN ISO 13402:2001: Surgical and dental hand instruments, Determination of resistance against autoclaving, corrosion and thermal exposure
DIN EN ISO 10993-4:2009-10: Biological evaluation of medical device -. Part 4: Selection of tests for interactions with blood
DIN EN ISO 10993-5:2009-10: Biological evaluation of medical device -. Part 5: Tests for in vitro Cytotoxicity
ISO 10993-10:2010: Biological evaluation of medical devices-Part 10: . Tests for Irritation and Skin Sensitization
Reprocessing at 100 cycles per DIN EN 285:2009: Sterilization Steam . sterilizers - Large sterilizers

Image /page/1/Picture/21 description: The image shows the word INTEGRA in a stylized font, with a logo to the right of the word. Below the word INTEGRA is the text "EXHIBIT 11 - Page 2 of 5". The text is in a simple, sans-serif font and is left-aligned.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "INTEGRA" in bold, sans-serif font. Below the word "INTEGRA" is the phrase "LIMIT UNCERTAINTY" in a smaller, sans-serif font. To the right of the word "INTEGRA" are four black squares of varying sizes, arranged in a descending order.

589 Davies Drive York, Pa 17402 Phone (717) 940-8335 Toll Free (800) 221-1344 Fax (717) 840-9347 www. Integralife.com

Summary of Performance Data:

Testing Performed	Results
Manual Cleaning Validation (Spore Log Reduction) per AAMI TIR30:2003.	Pass
Mechanical Cleaning Validation (Spore Log Reduction) per AAMI TIR30:2003.	Pass
Manual Cleaning Validation (Protein Analyses) per AAMI TIR30:2003.	Pass
Mechanical Cleaning Validation (Protein Analyses) per AAMI TIR30:2003.	Pass
Pre-Vacuum (wrapped) Steam Sterilization Validation per ISO at 132°C with anExposure Time of 4 minutes and a Minimum Drying Time of 20 minutes.	Pass
Biocompatibility Testing for both PEEK and PPSU materials according to ISO10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation & Sensitization)	Pass
Electromagnetic Compatibility & Safety Testing per IEC-60601-2-2:09.2007according to manufacture's rated voltage 3,000 VB and tested frequency of 450 kHz.	Pass
Load validation of intended use during surgery.	Pass
Mechanical Endurance Test	Pass
Reprocessing Test - 100 Autoclave Cycles per DIN EN 285 at 134°C with anexposure time of 5 minutes.	Pass
Corrosion Resistance Testing for all Metal parts according to Boiling Test DIN ENISO 13402.	Pass

Substantial Equivalence:

Integra™ Jarit® Take-Apart Endoscopic Instruments are substantially equivalent to the legally marketed predicate devices based on performance testing. The subject devices are equivalent to predicate devices with respect to intended use and materials, and design. Refer to attached predicate comparison charts 5-1A and 5-1B.

CONFIDENTIAL

{3}------------------------------------------------

'hart 5-1A: Comparison to KNF Predicate

	J. Jamner Surgical InstrumentsJarit Take-ApartEndoscopic InstrumentsSubject of Submission	J. Jamner Surgical InstrumentsJarit Surgical Instruments(Endoscopic Unipolar)	Aesculap, Inc.Modular Endoscopic Instruments
510(k) #Class/Pro CodeRegulation #Classification	II/KNF884.4160	K932456II/KNF884.4160	K010752II/ KNF884.4160
Intended Use	Coagulator-Cutter, Endoscopic, Unipolar (and Accessories)Intended for use in laparoscopic gynecologic surgery and otheroperative procedures under endoscopic observations. For usewhen a rigid endoscopic instrument for grasping, dissecting and/orother manipulation of soft tissue is determined to be appropriateby the surgeon. For those instruments with electrosurgicalcapability, current can be used for coagulation and/or cutting asdetermined necessary and appropriate by the surgeon.	Coagulator-Cutter, Endoscopic, Unipolar (andAccessories)For use by, or as directed by, a surgeon in endoscopicsurgery. For use when a rigid endoscopic instrumentfor grasping and/or dissecting of soft tissue isdetermined to be appropriate by the surgeon.Monopolar electrosurgical current can be used forcoagulation and/or cutting as determined necessaryand appropriate by the surgeon.	Coagulator-Cutter, Endoscopic, Unipolar (andAccessories)Intended to be used in tissue manipulation andcoagulation in monopolar laparoscopic gynecologyprocedures.
Patient ContactMaterials	Stainless Steel, PEEK, PPSU	Stainless Steel, PPSU	Stainless Steel, PEEK
Shaft Diameter	5 mm, 10 mm	5 mm, 10 mm	5 mm, 10 mm
Length	350mm, 425 mm	320mm, 370mm, 450 mm	310mm, 370mm, 420 mm
Sterility	Non-sterile	Non-sterile	Non-sterile
Sterilization	Steam Sterilizable	Steam Sterilizable	Steam Sterilizable
Utility	Reusable	Reusable	Reusable
Electrosurgical	Monopolar	Monopolar	Monopolar
Handles	Complies with IEC 60601-2-18w/wo Rotation, w/wo Ratchets	Complies with ANSI / AAMI HF18-1986w/wo Rotation, w/wo Ratchets	Complies with IEC 60601-2-18w/wo Rotation, w/wo Ratchets
Inserts	Graspers, Dissectors, Scissors, Biopsy Forceps,and Specialized Spoon ForcepsStainless Steel DIN 1.4021 (ASTM 420)	Suction Coagulators, Grasping Forceps, Scissors,Dissectors, Electrodes. Biopsy Punches,and Tissue PunchesStainless Steel DIN 1.4021 (ASTM 420)	Scissors and Forceps,Stainless Steel
ComponentsPicture of Device	3 pieces - Insert, Shaft, Handle	1 piece	4 pieces - Insert, Inner Shaft, Outer Shaft, Handle
	Image: Surgical instrument	Image: Surgical instrument	Image: Surgical instrument

CONFIDENIAL

Image /page/3/Picture/3 description: The image shows the word "INTEGRA" in a vertically stacked format. The letters are large and bold, making them easily readable. Above the word, there is a logo consisting of a square and three smaller squares arranged in a cluster.

January 31, 2012

{4}------------------------------------------------

Chart 5-1B: Comparison to GEI Predicate

10(k) #Class/Pro CodeRegulation #Classification	J. Jamner Surgical InstrumentsIntegra Jarit Take-ApartEndoscopic InstrumentsSubject of Submission	Applied Medical ResourcesLaparoscopic Dissector	Microline SurgicalRe-New Laparoscopic Instruments
	II/KNF884.4160	K103282II/GEI878.4400	K962119II/GEI878.4400
Intended Use	Coagulator-Cutter, Endoscopic, Unipolar (and Accessories)	Electrosurgical, Cutting & Coagulation device and accessories	Electrosurgical, Cutting & Coagulation device and accessories
	Intended for use in laparoscopic gynecologic surgery and otheroperative procedures under endoscopic observations. For usewhen a rigid endoscopic instrument for grasping, dissecting and/orother manipulation of soft tissue is determined to be appropriateby the surgeon. For those instruments with electrosurgicalcapability, current can be used for coagulation and/or cutting asdetermined necessary and appropriate by the surgeon.	For use during minimally invasive procedures forgrasping, mobilizing, dissecting and cauterizingtissue.	For use for cutting and dissecting various abdominaltissue during endoscopic (inclusive of laparoscopic)surgical procedures.
Patient ContactMaterials	Stainless Steel, PEEK, PPSU	Stainless Steel, Various Polymers including PEEK	Stainless Steel, PEEK
Shaft Diameter	5 mm, 10 mm	5 mm	5mm
Length	350mm, 425 mm	380mm, 450 mm	340mm, 420 mm
Sterility	Non-sterile	Sterile	Sterile and Non-sterile
Sterilization	Steam Sterilizable	Gamma Sterilizable	Steam Sterilizable
Utility	Reusable	Single Use, Disposable	Disposable/Reusable TipsReusable Shaft/Handle
Electrosurgical	Monopolar	Monopolar	Monopolar
Handles	Complies with IEC 60601-2-18	w Rotation, wo Ratchets	w/wo Rotation, w/wo Ratchets
Inserts	w/wo Rotation, w/wo RatchetsGraspers, Dissectors, Scissors, Biopsy Forceps,and Specialized Spoon ForcepsStainless Steel DIN 1.4021 (ASTM 420)	DissectorStainless Steel	Metzenbaum Scissors, Mini Scissors, Hook Scissors,Endocut Scissors, Micro ScissorsStainless Steel
Components	3 pieces - Insert, Shaft, Handle	1 piece	2 pieces - Tip Insert and Shaft/Handle
Picture of Device	Image: endoscopic instruments	Image: laparoscopic dissector	Image: laparoscopic instruments

CONFIDENIAL

Image /page/4/Picture/3 description: The image shows the word "INTEGRA" in a vertical orientation. To the right of the word is a logo that consists of four squares. The text is in a sans-serif font and is a dark color.

January 31, 2012

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird-like figure.

Public Health Service

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

FEB - 8 2012

Ms. Stephanie Sheesley Sr. Regulatory Affairs Manager Integra LifeSciences Corporation 589 Davies Drive YORK PA 17402

Re: K103726

Trade/Device Name: Integra™ Jarit® Take-Apart Endoscopic Instruments Regulation Number: 21 CFR§ 884.4160 Regulation Name: Unipolar endoscopic coagulator-cutter and accessories Regulatory Class: II Product Code: KNF Dated: January 29, 2012 Received: February 6, 2012 .

Dear Ms. Sheesley:

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

{6}------------------------------------------------

Page 2 -

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,

Benjamin K. Ticho

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Integra™ Jarit® Take-Apart Endoscopic Instruments

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

ー

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and	Page 1 of _

Regulation Number and Section

§ 884.4160 Unipolar endoscopic coagulator-cutter and accessories.

(a)
Identification. A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.(b)
Classification. Class II (performance standards).