(413 days)
Not Found
No
The device description and performance studies focus on mechanical and sterilization properties, with no mention of AI/ML or data processing capabilities.
No
The device is a surgical instrument used for grasping, dissecting, and manipulation of soft tissue, including electrosurgical capabilities for coagulation and cutting, but it does not treat or cure a disease or condition itself.
No
This device is described as an endoscopic surgical instrument for grasping, dissecting, and manipulating soft tissue, and for electrosurgical coagulation/cutting. Its intended use is for operative procedures, not for diagnosis.
No
The device description clearly outlines physical components (inserts, shafts, handles) and mentions testing related to materials, cleaning, sterilization, and mechanical endurance, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the instruments are for use in "laparoscopic gynecologic surgery and other operative procedures under endoscopic observations" for "grasping, dissecting and/or other manipulation of soft tissue." This describes a surgical tool used in vivo (within the body) during a procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such testing on bodily samples.
- Device Description: The description details surgical instruments (graspers, dissectors, scissors, etc.) used for physical manipulation of tissue.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic testing, or any of the typical components or processes associated with IVD devices.
Therefore, the Integra™ Jarit® Take-Apart Endoscopic Instruments are surgical instruments, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
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.
Product codes
KNF, GEI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
| 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 an Exposure Time of 4 minutes and a Minimum Drying Time of 20 minutes. | Pass |
| Biocompatibility Testing for both PEEK and PPSU materials according to ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation & Sensitization) | 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 |
| 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 an exposure time of 5 minutes. | Pass |
| Corrosion Resistance Testing for all Metal parts according to Boiling Test DIN EN ISO 13402. | Pass |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K932456, K010752, K103282, K962119, K043013
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Manager
Integra York PA, Inc.
589 Davies Drive, York, PA 17402 USA
Phone: (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:
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.
Indications For Use:
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.
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 an | |
| Exposure Time of 4 minutes and a Minimum Drying Time of 20 minutes. | Pass |
| Biocompatibility Testing for both PEEK and PPSU materials according to ISO | |
| 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation & Sensitization) | 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 |
| 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 an | |
| exposure time of 5 minutes. | Pass |
| Corrosion Resistance Testing for all Metal parts according to Boiling Test DIN EN | |
| ISO 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 Instruments
Jarit Take-Apart
Endoscopic Instruments
Subject of Submission | J. Jamner Surgical Instruments
Jarit Surgical Instruments
(Endoscopic Unipolar) | Aesculap, Inc.
Modular Endoscopic Instruments |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) #
Class/Pro Code
Regulation #
Classification | II/KNF
884.4160 | K932456
II/KNF
884.4160 | K010752
II/ KNF
884.4160 |
| Intended Use | Coagulator-Cutter, Endoscopic, Unipolar (and Accessories)
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. | Coagulator-Cutter, Endoscopic, Unipolar (and
Accessories)
For use by, or as directed by, a surgeon in endoscopic
surgery. For use when a rigid endoscopic instrument
for grasping and/or dissecting of soft tissue is
determined to be appropriate by the surgeon.
Monopolar electrosurgical current can be used for
coagulation and/or cutting as determined necessary
and appropriate by the surgeon. | Coagulator-Cutter, Endoscopic, Unipolar (and
Accessories)
Intended to be used in tissue manipulation and
coagulation in monopolar laparoscopic gynecology
procedures. |
| Patient Contact
Materials | 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 60601-2-18
w/wo Rotation, w/wo Ratchets | Complies with ANSI / AAMI HF18-1986
w/wo Rotation, w/wo Ratchets | Complies with IEC 60601-2-18
w/wo Rotation, w/wo Ratchets |
| Inserts | Graspers, Dissectors, Scissors, Biopsy Forceps,
and Specialized Spoon Forceps
Stainless Steel DIN 1.4021 (ASTM 420) | Suction Coagulators, Grasping Forceps, Scissors,
Dissectors, Electrodes. Biopsy Punches,
and Tissue Punches
Stainless Steel DIN 1.4021 (ASTM 420) | Scissors and Forceps,
Stainless Steel |
| Components
Picture 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 Code
Regulation #
Classification | | J. Jamner Surgical Instruments
Integra Jarit Take-Apart
Endoscopic Instruments
Subject of Submission | Applied Medical Resources
Laparoscopic Dissector | Microline Surgical
Re-New Laparoscopic Instruments |
|-------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| | | II/KNF
884.4160 | K103282
II/GEI
878.4400 | K962119
II/GEI
878.4400 |
| 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 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. | For use during minimally invasive procedures for
grasping, mobilizing, dissecting and cauterizing
tissue. | For use for cutting and dissecting various abdominal
tissue during endoscopic (inclusive of laparoscopic)
surgical procedures. |
| Patient Contact
Materials | | 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 Tips
Reusable 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 Ratchets
Graspers, Dissectors, Scissors, Biopsy Forceps,
and Specialized Spoon Forceps
Stainless Steel DIN 1.4021 (ASTM 420) | Dissector
Stainless Steel | Metzenbaum Scissors, Mini Scissors, Hook Scissors,
Endocut Scissors, Micro Scissors
Stainless 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:
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.
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)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastro-Renal, and | Page 1 of _ |