Integra™ Jarit® Video Assisted Thoracic Surgery (VATS) Instruments are manually operated instruments designed to perform specific functions such as cutting, grasping, clamping, dissecting, probing, draining, aspirating, suturing or ligating during open, mini-open, or thoracoscopic surgical procedures.

Device Description

Integra™ Jarit® Video Assisted Thoracic Surgery (VATS) Instruments are a family of manual, stainless steel instruments consisting of clamps, forceps, needle holders, scissors, knot tiers/pushers, and suction instruments. These reusable devices are packaged non-sterile and are steam sterilizable.

AI/ML Overview

The Integra™ Jarit® Video Assisted Thoracic Surgery (VATS) Instruments are manual, stainless steel surgical instruments. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical study on AI performance. Therefore, most of the requested information regarding AI study details (like sample sizes for test/training sets, expert qualifications, MRMC studies, etc.) is not applicable to this submission.

Here's a breakdown of the acceptance criteria and performance data as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Testing Performed	Acceptance Criteria (Implicit)	Reported Device Performance
Manual Cleaning Validation (Protein Analyses) per AAMI TIR30:2003.	Conformance to AAMI TIR30:2003 guidelines for cleaning, specifically for protein removal. (Details of specific protein levels are not provided.)	Pass
Mechanical Cleaning Validation (Protein Analyses) per AAMI TIR30:2003.	Conformance to AAMI TIR30:2003 guidelines for cleaning, specifically for protein removal. (Details of specific protein levels are not provided.)	Pass
Pre-Vacuum (wrapped) Steam Sterilization Validation per ANSI/AAMI ST79:2010 & A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an Exposure Time of 4 minutes.	Sterilization to achieve sterility assurance level (SAL). (Specific SAL not detailed, but implied by standard conformance.)	Pass
Repeated Autoclave Testing, Boiling Water Testing, Copper Sulfate Corrosion Testing and Thermal Testing per ISO 13402 and ASTM F 1089-02.	Maintenance of integrity and functionality after exposure to specified conditions, including resistance to corrosion and thermal exposure. (Specific pass/fail thresholds not detailed.)	Pass

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this document describes the validation of physical surgical instruments, not an AI device or a study involving human-in-the-loop performance with an AI. The "test set" here refers to the physical instruments tested. The report indicates the testing was performed, but details on the number of instruments or specific units tested are not provided. The testing was conducted by Integra York PA, Inc., likely within the US, but explicit provenance is not stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. Ground truth in this context would refer to the objective standards set by the cited performance standards (e.g., a specific level of protein removal, a defined sterility assurance level, or physical properties of materials). The assessment of "pass" or "fail" is based on these objective criteria as measured in laboratory settings, not on expert interpretation of images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments. The performance tests here are objective measurements against defined 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

This is not applicable. This submission is for manual surgical instruments, not an AI device.

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

This is not applicable. This submission is for manual surgical instruments, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for these tests is based on established industry and international standards for medical device performance, material science, and sterilization. These include:

ANSI/AAMI ST79:2010 & A1:2010 (Sterilization)
ANSI/AAMI/ISO 14937:2009 (Sterilization)
ASTM TIR 30:2003 (Cleaning)
ASTM F 1089-02 (Corrosion)
ISO 13402:1995 (Resistance against autoclaving, corrosion, thermal exposure)
ISO 7153-1:2001 (Metallic Materials - Stainless Steel)
ASTM F899-11 (Wrought Stainless Steels for Surgical Instruments)

The "ground truth" is defined by the requirements and methodologies within these standards.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable.

Summary

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

K120012

Image /page/0/Picture/1 description: The image shows the logo for INTEGRA. The word INTEGRA is in all caps and in bold font. Below the word INTEGRA is the phrase "LIMIT UNCERTAINTY" in a smaller font. To the right of the word INTEGRA are three black squares of varying sizes.

589 Davies Driv York Pa 17402 hone (717) 940-8 Toll Free (800) 221 ax (717) 840-93

510(k) Summary

SEP 11 2012

Submitted by:	Integra York PA, Inc.589 Davies Drive, York, PA 17402 USA
Contact Person:	Stephanie Sheesley, Sr. Regulatory Affairs ManagerIntegra York PA, Inc.589 Davies Drive, York, PA 17402 USAPhone: (717) 717-840-2774 Fax: (717) 840-9347
Date Prepared:	December 22, 2011
Device Trade Name:	IntegraTM Jarit® Video Assisted Thoracic Surgery (VATS)Instruments
Device Common Name:	Minimally Invasive Surgical Instruments
Classification Name:	Endoscope and accessories
Device Class:	Class II
Product Code:	GCJ
CFR Classification:	21 CFR 876.1500

Device Description:

Indications For Use:

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

Image /page/1/Picture/0 description: The image shows the word "INTEGRA" in bold, black letters. Below the word "INTEGRA" are the words "LIMIT UNCERTAINTY" in a smaller font. To the right of the word "INTEGRA" are four black squares of varying 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) #	Device	Product Code	Manufacturer
K945474	Scanlan® ThoracoscopicScissors, Clamps, Forceps, Needle Holder	GCJ	Scanlan Intl, Inc.
K925198	Kaiser “No Cannula” Thoracoscopic/Laparoscopic Instruments	GCJ	Pilling Co.
K932456	Jarit Surgical Instruments	KNF	Integra York PA, Inc.
K941565	Jarit Recommended SinusInstruments	EOB	Integra York PA, Inc.

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® Video Assisted Thoracic Surgery Instruments conform to the following standards:

ANSI/AAMI ST79:2010 & A1:2010 Comprehensive guide to steam sterilization . and sterility assurance in health care facilities
ANSI/AAMI/ISO 14937:2009 Sterilization of health care products-General . requirements for characterization of a sterilizing_agent and the development, validation, and routine control of a sterilization process
ASTM TIR 30:2003 A Compendium of processes, materials, test methods, and . acceptance criteria for cleaning reusable medical devices
ASTM F 1089-02 Standard test method for corrosion of surgical instruments ●
t ISO 13402:1995 Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure
ISO 7153-1:2001 Surgical instruments- Metallic Materials- Part 1: Stainless Steel .
. ASTM F899-11 Standard Specification for Wrought Stainless Steels for Surgical Instruments

Performance Data:

Testing Performed	Results
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 ANSI/AAMI ST79:2010& A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an ExposureTime of 4 minutes.	Pass
Repeated Autoclave Testing, Boiling Water Testing, Copper Sulfate CorrosionTesting and Thermal Testing per ISO 13402 and ASTM F 1089-02.	Pass

Substantial Equivalence:

Integra™ Jarit® Video Assisted Thoracic Surgery Instruments are substantially equivalent to the legally marketed predicate devices based on intended use, materials, and design.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

Integra LifeSciences Corporation % Integra York PA, Incorporated Ms. Stephanie Sheesley Senior Regulatory Affairs Manager 589 Davis Drive York, Pennsylvania 17402

SEP 11 2012

Re: K120012

Trade/Device Name: Integra™ Jarit® Video Assisted Thoracic Surgery Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 8, 2012 Received: August 10, 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

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

Page 2 - Ms. Stephanie Sheesley

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 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,

for Datt in 71

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

Enclosure

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

Indications For Use

K120012 510(k) Number (if known): __

Integra™ Jarit® Video Assisted Thoracic Surgery (VATS) Instruments Device Name: :

Indications for Use:

Prescription Use_ > (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nulhe Siste formkn

Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120012

Page 1 of 1

Image /page/4/Picture/16 description: The image shows the word "INTEGRA" in all caps and in a sans-serif font. Below the word "INTEGRA" is a smaller word that is illegible. To the right of the word "INTEGRA" is a graphic of four squares of different sizes stacked on top of each other.

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.