INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS

K120012 · Integra LifeSciences Corporation · GCJ · Sep 11, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120012
• Device Name: INTEGRA JARIT VIDEO ASSISTED THORACIC SURGERY INSTRUMENTS
• Applicant: Integra LifeSciences Corporation
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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 Story

Family of manual, stainless steel surgical instruments; includes clamps, forceps, needle holders, scissors, knot tiers/pushers, and suction instruments. Used by surgeons in OR settings during open, mini-open, or thoracoscopic procedures. Devices are reusable, non-sterile, and steam sterilizable. Instruments facilitate tissue manipulation and surgical access; provide mechanical assistance for standard surgical tasks.

Clinical Evidence

Bench testing only. Validated manual and mechanical cleaning (protein analysis) per AAMI TIR30:2003. Validated pre-vacuum steam sterilization per ANSI/AAMI ST79:2010 and ANSI/AAMI/ISO 14937:2009. Confirmed material resistance via repeated autoclave, boiling water, copper sulfate corrosion, and thermal testing per ISO 13402 and ASTM F 1089-02.

Technological Characteristics

Manual, reusable stainless steel surgical instruments. Materials conform to ISO 7153-1:2001 and ASTM F899-11. Sterilization via steam (autoclave). No electronic components or software.

Indications for Use

Indicated for patients undergoing open, mini-open, or thoracoscopic surgical procedures requiring cutting, grasping, clamping, dissecting, probing, draining, aspirating, suturing, or ligating.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Scanlan® Thoracoscopic Scissors, Clamps, Forceps, Needle Holder (K945474)
• Kaiser “No Cannula” Thoracoscopic/Laparoscopic Instruments (K925198)
• Jarit Surgical Instruments (K932456)
• Jarit Recommended Sinus Instruments (K941565)

Submission Summary (Full Text)

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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.<br>589 Davies Drive, York, PA 17402 USA |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephanie Sheesley, Sr. Regulatory Affairs Manager<br>Integra York PA, Inc.<br>589 Davies Drive, York, PA 17402 USA<br>Phone: [phone] Fax: [phone] |
| Date Prepared: | December 22, 2011 |
| Device Trade Name: | IntegraTM Jarit® Video Assisted Thoracic Surgery (VATS)<br>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:

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.

### Indications For Use:

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.

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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 [phone]
Toll Free [phone]
Fax [phone]
www. Integralife.com

| 510(k) # | Device | Product Code | Manufacturer |
|----------|--------------------------------------------------------------------|--------------|-----------------------|
| K945474 | Scanlan® Thoracoscopic<br>Scissors, Clamps, Forceps, Needle Holder | GCJ | Scanlan Intl, Inc. |
| K925198 | Kaiser “No Cannula” Thoracoscopic/<br>Laparoscopic Instruments | GCJ | Pilling Co. |
| K932456 | Jarit Surgical Instruments | KNF | Integra York PA, Inc. |
| K941565 | Jarit Recommended Sinus<br>Instruments | 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<br>& A1:2010 and ANSI/AAMI/ISO 14937:2009 at 270°F (132°C) with an Exposure<br>Time of 4 minutes. | Pass |
| Repeated Autoclave Testing, Boiling Water Testing, Copper Sulfate Corrosion<br>Testing 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.

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# 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

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### 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 [phone] or [phone] 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

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## Indications For Use

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

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

Indications for Use:

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.

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

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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.