(161 days)
This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of
-
- Endoscopic marking,
-
- Hemostasis for
- · Mucosal/submucosal defects less than 3 cm
- · Bleeding ulcers,
- · Arteries less than 2 mm,
- · Polyps less than 1.5 cm in diameter,
- · Diverticula in the colon, and
- · Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection,
-
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel,
- As a supplementary method for closure of GI tract luminal perforations less than 20mm that can be treated conservatively
- Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.
The Instinct Plus Endoscopic Clipping Device is a sterile, single use metallic clip used for tissue approximation and hemostasis in the gastrointestinal tract. The metallic clip is 14.4 mm long and has an opening span of 16 mm. The clip is preloaded on a 230 cm long introducer comprised of a coated coil spring, drive wire and deployment handle. The clip may be deployed to the site of interest using a straight viewing flexible endoscope with a minimum accessory channel of 2.8 mm, or side viewing flexible endoscope with a minimum accessory channel of 4.2 mm. The clip can be rotated for positioning by rotating the handle of the introducer and may be reopened and closed up to five times prior to deployment.
The Instinct Plus Endoscopic Clipping Device is supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with one-year shelf life.
This is a 510(k) premarket notification for the Instinct Plus Endoscopic Clipping Device. The document claims substantial equivalence to two predicate devices: the K151802 Resolution™ 360 Clip and the K132809 Instinct Endoscopic Hemoclip.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists "design input requirements" that performance testing was conducted to meet. These essentially serve as acceptance criteria. However, explicit numerical or categorical acceptance values for each criterion are not provided in the summary. Instead, it generally states that the device "met the design input requirements."
Table: Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Design Input Requirement) | Reported Device Performance |
|---|---|
| 1. Sterility | Met design input requirements |
| 2. Packaging | Met design input requirements |
| 3. Biocompatibility | Met design input requirements |
| 4. Advance device into the GI tract through a compatible endoscope | Met design input requirements |
| 5. Position and approximate target site | Met design input requirements |
| 6. Deploy clip onto targeted GI tissue | Met design input requirements |
| 7. Removal of device from the endoscope | Met design input requirements |
| 8. Force of clip retention at tissue | Met design input requirements |
| 9. Force of clip compression at tissue | Met design input requirements |
| 10. Strength of clip assembly | Met design input requirements |
| 11. Strength of clip housing | Met design input requirements |
| 12. MRI Testing | Met design input requirements |
| 13. Corrosion testing | Met design input requirements |
| 14. Force to deploy clip on tissue handle | Met design input requirements |
| 15. Strength of Introducer Coil Cath | Met design input requirements |
| 16. Strength of Handle and Drivewire | Met design input requirements |
2. Sample Size Used for the Test Set and Data Provenance:
The document is a 510(k) summary and does not provide specific details on the sample sizes used for each performance test. It mentions "performance testing was conducted," but no numbers of devices tested, number of simulated cases, or specific patient data are given. As this filing is for a mechanical device and discusses performance data but does not explicitly mention clinical studies using patient data, it is highly likely that the testing involved lab-based, benchtop, or simulated use testing of the device's physical and functional characteristics. Therefore, there is no mention of retrospective or prospective data or country of origin for a clinical test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since the testing described is primarily focused on mechanical and functional performance (e.g., strength, deployment, retention), the concept of "ground truth" established by human experts for diagnostic accuracy studies (like radiologists) is not applicable here. The "ground truth" for these performance tests would be defined by engineering specifications, material properties, and functional benchmarks derived from predicate devices or established standards.
4. Adjudication Method for the Test Set:
Not applicable, as this is primarily a performance and mechanical testing summary, not a study involving human interpretation or diagnostic accuracy where adjudication would be necessary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC study was not done. The document describes performance testing of the device itself, not a comparative effectiveness study involving human readers with and without AI assistance (which is typical for AI/CAD devices).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This is not an AI/CAD device.
7. The Type of Ground Truth Used:
For the performance data, the "ground truth" would be established by:
- Engineering Specifications: Pre-defined design limits and tolerances for force, dimensions, durability, etc.
- Material Standards: Compliance with known material properties.
- Predicate Device Performance: Benchmarking against the known performance characteristics of the legally marketed predicate devices.
- Established Test Methods: Adherence to validated laboratory testing protocols.
8. The Sample Size for the Training Set:
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. This is not a machine learning or AI device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 5, 2020
Cook Endoscopy Karthik Pillai Regulatory Scientist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K192697
Trade/Device Name: Instinct Plus Endoscopic Clipping Device Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated: January 28, 2020 Received: January 29, 2020
Dear Karthik Pillai:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K192697
Device Name
Instinct Plus Endoscopic Clipping Device
Indications for Use (Describe)
This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of
-
- Endoscopic marking,
-
- Hemostasis for
- · Mucosal/submucosal defects less than 3 cm
- · Bleeding ulcers,
- · Arteries less than 2 mm,
- · Polyps less than 1.5 cm in diameter,
- · Diverticula in the colon, and
- · Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection,
-
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel,
-
As a supplementary method for closure of GI tract luminal perforations less than 20mm that can be treated conservatively
-
Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K192697 Page 1 of 7
Image /page/3/Picture/1 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is written in white, sans-serif font, with the registered trademark symbol next to it. Below "COOK", the word "MEDICAL" is written in white, sans-serif font, set against a black background.
510(k) SUMMARY
COOK ENDOSCOPY 4900 BETHANIA STATION ROAD WINSTON-SALEM, NC 27105 U.S.A. PHONE: 336.744.0157 TOLL FREE: 800.245.4707 WWW.COOKMEDICAL.COM
Instinct Plus Endoscopic Clipping Device 21 CFR §876.4400 Date Prepared: 4 March 2020
| Submitted By: | |
|---|---|
| Submission: | Traditional 510(k) Premarket Notification |
| Applicant: | Cook Endoscopy (Wilson-Cook Medical, Inc) |
| Applicant Address: | 4900 Bethania Station RoadWinston-Salem, NC 27105 |
| Primary Contact: | Karthik Pillai, Ph.D., RAC |
| Contact Phone Number | 812-335-3575 x104929 |
| Device Information: | |
| Device Name: | Instinct Plus Endoscopic Clipping Device |
| Common Name: | Endoscopic Clipping Device |
| Classification Number: | 21 CFR §876.4400 |
| Classification Name: | Hemorrhoidal Ligator |
| Product Code: | PKL |
| Product Code Name: | Hemostatic Metal Clip for the Gi Tract |
| Regulatory Class: | II |
Predicate Devices:
Device Description:
The Instinct Plus Endoscopic Clipping Device is a sterile, single use metallic clip used for tissue approximation and hemostasis in the gastrointestinal tract. The metallic clip is 14.4 mm long and has an opening span of 16 mm. The clip is preloaded on a 230 cm long introducer comprised of a coated coil spring, drive wire and deployment handle. The clip may be deployed to the site of interest using a straight viewing flexible endoscope with a minimum accessory channel of 2.8 mm,
{4}------------------------------------------------
K192697 Page 2 of 7
or side viewing flexible endoscope with a minimum accessory channel of 4.2 mm. The clip can be rotated for positioning by rotating the handle of the introducer and may be reopened and closed up to five times prior to deployment.
The Instinct Plus Endoscopic Clipping Device is supplied sterilized by ethylene oxide gas in a peel-open package and intended for one-time use. The product is packaged with one-year shelf life.
Intended Use:
This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of
-
- Endoscopic marking.
-
- Hemostasis for
- Mucosal/submucosal defects less than 3 cm .
- Bleeding ulcers, .
- Arteries less than 2 mm. .
- Polyps less than 1.5 cm in diameter, .
- Diverticula in the colon, and .
- Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection .
-
- Anchoring to affix jejunal feeding tubes to the wall of the small bowel
-
- As a supplementary method for closure of GI tract luminal perforations less than 20mm that can be treated conservatively
-
- Anchoring to affix fully covered esophageal self-expanding metal stents to the wall of the esophagus in patients with fistulas, leaks, perforations, or disunion.
Technological Characteristics
The Instinct Plus Endoscopic Clipping Device has identical or similar technological characteristics, and mode of operation compared to the predicate devices. The subject device and the predicate devices have the same Intended Use and similar Indications for Use. The comparison of technological characteristics is provided in table 1. The primary difference between the subject device and the predicates are materials, dimensions and design elements. These differences do not affect device performance as demonstrated by biological and functional testing of the subject device.
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K192697
Page 3 of 7
| DeviceCharacteristics | Primary PredicateResolution™ 360 Clip | Secondary PredicateInstinct Endoscopic Hemoclip | Subject DeviceInstinct Plus Endoscopic ClippingDevice | Comparison |
|---|---|---|---|---|
| 510(k) | K151802 | K132809 | Subject of this submission | N/A |
| Manufacturer | Boston Scientific Corporation | Wilson-Cook Medical,Inc./Cook Endoscopy | Wilson-Cook Medical, Inc./CookEndoscopy | Same manufacturer as SecondaryPredicate |
| Device Class | II | II | II | Identical |
| Indications forUse | The Resolution™ 360 Clip isindicated for clip placementwithin the gastrointestinal (GI)tract for the purpose of:1. Endoscopic marking2. Hemostasis for:• Mucosal/sub-mucosaldefects < 3 cm• Bleeding ulcers• Arteries < 2 mm• Polyps < 1.5 cm indiameter• Diverticula in the colon• Prophylactic clipping toreduce the risk of delayedbleeding post lesionresection3. Anchoring to affix jejunalfeeding tubes to the wall ofthe small bowel; andAnchoring to affix fullycovered esophageal self-expanding metal stents to thewall of the esophagus4. As a supplemental closuremethod of luminalperforations < 20 mm thatcan be treatedconservatively | This device is used forendoscopic clip placementwithin the gastrointestinal tractfor the purpose of1. Endoscopic marking,2. Hemostasis for:• Mucosal/submucosaldefects less than 3 cm inthe upper GI tract,• Bleeding ulcers,• Arteries less than 2 mm,and• Polyps less than 1.5 cm indiameter in the GI tract.This device is not intended forthe repair of GI tract luminalperforations. | This device is used for endoscopicclip placement within thegastrointestinal tract for the purposeof1. Endoscopic marking,2. Hemostasis for• Mucosal/submucosal defectsless than 3 cm• Bleeding ulcers,• Arteries less than 2 mm,• Polyps less than 1.5 cm indiameter,• Diverticula in the colon, and• Prophylactic clipping toreduce the risk of delayedbleeding post lesion resection,3. Anchoring to affix jejunalfeeding tubes to the wall of thesmall bowel,4. As a supplementary method forclosure of GI tract luminalperforations less than 20mm thatcan be treated conservatively5. Anchoring to affix fully coveredesophageal self-expanding metalstents to the wall of theesophagus in patients with | Same indications for use as primarypredicate and added indicationscompared to the secondary predicate.The indications are identical toprimary predicate and do not raiseadditional questions of safety andeffectiveness (S&E). |
| Device | Primary Predicate | Secondary Predicate | Subject Device | Comparison |
| Characteristics | Resolution™ 360 Clip | Instinct Endoscopic Hemoclip | Instinct Plus Endoscopic ClippingDevice | |
| Packaging | Pouch | Pouch | Pouch | Identical |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Identical |
| Shelf Life | 3 years | 3 Years | 1 year | The subject device is supported for ashelf life of one year. |
| Configuration | Delivery system and clip | Delivery system and clip | Delivery system and clip | Identical |
| MR Conditional | Yes | Yes | Yes | Identical |
| Clip | ||||
| Number ofProngs | 2 | 2 | 2 | Identical |
| Jaw Width | 11 mm | 16 mm | 16 mm | The jaw width of the open clip islarger than primary predicate, andidentical to the secondary predicate.This difference does not affect S&E. |
| Clip Geometry | Cylindrical housing, roundedarms with serrated tip | Cylindrical housing, flat armswith serrated tip | Cylindrical housing, rounded armswith serrated tip | Clip geometry is identical to theprimary predicate, but slightlydifferent than the secondary predicate.No effect on S&E. |
| Number ofOpen-CloseCycles Prior toDeployment | 5 | 5 | 5 | Identical |
| HandleControlled ClipRotation | Yes | Yes | Yes | Identical |
| Material | Stainless steel, Cobalt chromeand Styrene | Stainless-steel and Nitinol | Stainless-steel, Delrin, and Nitinol | Difference in material evaluated bybiological and performance testingand shown not to affect S&E. |
| Introducer | ||||
| Working length | 155, 235 cm | 230 cm | 230 cm | Subject device only sold in one devicelength which is similar to the largersize of primary predicate and identicalin length to secondary predicate |
| DeviceCharacteristics | Primary PredicateResolution™ 360 Clip | Secondary PredicateInstinct Endoscopic Hemoclip | Subject DeviceInstinct Plus Endoscopic ClippingDevice | Comparison |
| IntroducerDiameter(nominal) | 7 Fr | 7 Fr | 7 Fr | Identical |
| MinimumWorkingChannel ofEndoscope | 2.8 mm | 2.8 mm | 2.8 mm for forward viewingendoscope, and 4.2 mm for side-viewing endoscope | The subject device has been evaluatedfor compatibility with side-viewingendoscopes and found to becompatible with scopes with at least a4.2 mm working-channel. |
| Material:Introducer CoilSpring | Stainless steel | Stainless Steel, Polyether blockpolyamide copolymer | Stainless steel, Polyether blockpolyamide copolymer | |
| Drive Wire | Stainless steel | Nitinol | Nitinol, polyarylamide | Difference in material evaluated bybiological testing and performancetesting and shown not to affect S&E. |
| Material:Handle | Thermoplastic elastomers,polyethylene and polyester | Polystyrene, polypropylene andpolycarbonate | Polystyrene, polypropylene andpolycarbonate |
Table 1. Comparison between predicates and the subject device
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K192697
Page 4 of 7
{7}------------------------------------------------
K192697 Page 5 of 7
Performance Data:
Performance testing was conducted to meet the following design input requirements:
-
- Sterility
-
- Packaging
-
- Biocompatibility
-
- Advance device into the GI tract through a compatible endoscope
-
- Position and approximate target site
-
- Deploy clip onto targeted GI tissue
-
- Removal of device from the endoscope
-
- Force of clip retention at tissue
-
- Force of clip compression at tissue
-
- Strength of clip assembly
-
- Strength of clip housing
-
- MRI Testing
{8}------------------------------------------------
K192697 Page 6 of 7
-
Corrosion testing
-
Force to deploy clip on tissue handle
{9}------------------------------------------------
K192697 Page 7 of 7
-
- Strength of Introducer Coil Cath
-
- Strength of Handle and Drivewire
Conclusion:
The results of these tests provide reasonable assurance that the Instinct Plus Endoscopic Clipping Device met the design input requirements based on the intended use. The subject device does not raise new questions of safety or effectiveness as compared to the predicate devices.
§ 876.4400 Hemorrhoidal ligator.
(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.