(30 days)
This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking. - 2. 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, - 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel, 4. As a supplementary method for closure of GI tract luminal perforations less than 20 mm that can be treated conservatively. 5. 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 three-year shelf life.
The provided text describes a 510(k) premarket notification for the "Instinct Plus Endoscopic Clipping Device." This is a regulatory submission for a medical device, where the manufacturer demonstrates that their new device is substantially equivalent to a legally marketed predicate device. The information presented is primarily focused on demonstrating this equivalence rather than a full clinical study report on diagnostic accuracy or comparative effectiveness of an AI product.
Therefore, many of the requested items (e.g., sample sizes for training/test sets, number of experts for ground truth, MRMC study results, standalone performance of an AI algorithm, etc.) are not applicable to this type of document, as it concerns a physical medical device (an endoscopic clipping device) and not an AI-based diagnostic tool. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance specifications of the physical device and bench testing results, not a clinical study to establish diagnostic performance.
However, I can extract the relevant information regarding the device's technical specifications and the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
The document focuses on demonstrating substantial equivalence to a predicate device (K192697) by tightening dimensional specifications and performing non-clinical bench testing. The "acceptance criteria" here relate to the device's functional performance during these tests.
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Deployment Consistency | Consistent deployment of the clip (to fulfill intended use) | Enabled consistent deployment of the clip |
| Strength of Distal Coil Cath Tabs | Met acceptance criteria | Confirmed to have met acceptance criteria during validation testing |
| Shelf Life | No impact on shelf life despite a change in the supported duration (3 years vs 1 year for predicate) | Supported for three-year shelf life based on the same method as the predicate, with no impact from the modification. |
| Dimensional Specification and Tolerance (Proximal end of catheter attach component) | Improved deployment consistency and addressed events related to inability to deploy clip observed in clinical use. | The change successfully addressed these issues. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated as a number of devices or clinical cases. The "test set" here refers to devices used in bench testing.
- Data provenance: The testing was "non-clinical bench testing" and "validation testing" performed by the manufacturer, Cook Medical Inc. This is not clinical data (e.g., country of origin, retrospective/prospective) in the context of human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This pertains to an AI/diagnostic product that requires expert-annotated ground truth. This document describes a physical medical device and its engineering performance.
4. Adjudication method for the test set
- Not applicable. This pertains to expert review and consensus for AI/diagnostic product ground truth.
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 physical medical device, not an AI product or a diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an AI algorithm.
7. The type of ground truth used
- Engineering specifications and functional performance criteria. The "ground truth" for this device's performance is whether it meets its design requirements and functional specifications (e.g., consistent clip deployment, strength of components). This is established through engineering and quality control procedures, not expert consensus on medical images or pathology.
8. The sample size for the training set
- Not applicable. This document describes a physical medical device and its engineering performance, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. This document describes a physical medical device and its engineering performance.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 25, 2021
Wilson-Cook Medical Inc. Scottie Fariole Regulatory Science Specialist 4900 Bethania Station Road Winston-Salem, NC 27105
Re: K212323
Trade/Device Name: Instinct Plus Endoscopic Clipping Device Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: July 23, 2021 Received: July 26, 2021
Dear Scottie Fariole:
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 control's 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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
Submission Number (if known)
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: 1. 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 20 mm 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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COOK®
MEDICAL
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
510(k) Summary Name: Wilson-Cook Medical, Inc. /Cook Endoscopy Address: 4900 Bethania Station Road Winston-Salem, North Carolina 27105 Phone: (336)744-0157 Fax: (336)201-5994 Contact: Scottie Fariole, Regulatory Science Specialist Date: August 25, 2021 Device Name: Instinct Plus Endoscopic Clipping Device Common Name: Hemostatic Metal Clip For The Gi Tract or Endoscopic Clipping Device Classification Name: Hemorrhoidal Ligator (21 CFR 876.4400, Product Code PKL) Product Code Name: Hemostatic Metal Clip For The Gi Tract Regulatory Class: Class II Device Predicate Instinct Plus Endoscopic Clipping Device (K192697) Device: Description of the The Instinct Plus Endoscopic Clipping Device is a sterile, single Device: 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
Page 1 of 4
life.
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 three-year shelf
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Cook Endoscopy - Special 510(k) Instinct Plus Endoscopic Clipping Device
Intended Use: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of: 1. Endoscopic marking, 2. 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, 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel, 4. As a supplementary method for closure of GI tract luminal perforations less than 20 mm that can be treated conservatively, 5. 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 The subject Instinct Plus Endoscopic Clipping Device is Characteristics: substantially equivalent to the referenced Instinct Plus Endoscopic Clipping Device (K192697) with respect to Indications for Use, Principles of Operation and overall device design, dimensions, shape and material. The change that is the subject of this 510(k) is to tighten the dimensional specification and tolerance on the proximal end of the catheter attach component of the introducer. The purpose of the change is to improve deployment consistency and address events related to inability to deploy clip observed in clinical use. A comparison of the key feature of the subject device and predicate device is included in the Substantial Equivalence Comparison table.
Summary Substantial Equivalence Comparison Table:
| Parameter | Instinct Plus EndoscopicClipping Device (SubjectDevice) | Instinct Plus EndoscopicClipping Device (K192697) | Comparison |
|---|---|---|---|
| Indications forUse | This device is used forendoscopic clip placementwithin the gastrointestinaltract for the purpose of1. Endoscopic marking,2. Hemostasis for• Mucosal/submucosaldefects less than 3 cm• Bleeding ulcers, | This device is used forendoscopic clip placementwithin the gastrointestinaltract for the purpose of1. Endoscopic marking,2. Hemostasis for• Mucosal/submucosaldefects less than 3 cm• Bleeding ulcers, | Identical |
| Parameter | Instinct Plus EndoscopicClipping Device (SubjectDevice) | Instinct Plus EndoscopicClipping Device (K192697) | Comparison |
| • Arteries less than 2 mm,• Polyps less than 1.5 cmin diameter,• Diverticula in the colon,and• Prophylactic clipping toreduce the risk of delayedbleeding post lesionresection,3. Anchoring to affixjejunal feeding tubes tothe wall of the smallbowel,4. As a supplementarymethod for closure of GItract luminal perforationsless than 20 mm that canbe treated conservatively,5. Anchoring to affix fullycovered esophageal self-expanding metal stents tothe wall of the esophagusin patients with fistulas,leaks, perforations, ordisunion. | • Arteries less than 2 mm,• Polyps less than 1.5 cmin diameter,• Diverticula in the colon,and• Prophylactic clipping toreduce the risk of delayedbleeding post lesionresection,3. Anchoring to affixjejunal feeding tubes tothe wall of the smallbowel,4. As a supplementarymethod for closure of GItract luminal perforationsless than 20 mm that canbe treated conservatively,5. Anchoring to affix fullycovered esophageal self-expanding metal stents tothe wall of the esophagusin patients with fistulas,leaks, perforations, ordisunion. | ||
| Packaging | Pouch | Pouch | Identical |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Identical |
| Shelf Life | 3 Years | 1 Year | Subject device issupported for three-year shelf life based onthe same methoddescribed in theprevious 510(k).Change in Shelf Lifewas not the result ofdevice modification,nor did the changeimpact shelf life. |
| Configuration | Delivery system and clip | Delivery system and clip | Identical |
| MRConditional | Yes | Yes | Identical |
| Clip | |||
| Number ofProngs | 2 | 2 | Identical |
| Parameter | Instinct Plus EndoscopicClipping Device (Subject Device) | Instinct Plus EndoscopicClipping Device (K192697) | Comparison |
| Jaw Width | 16 mm | 16 mm | Identical |
| Clip Geometry | Cylindrical housing, rounded arms with serrated tip | Cylindrical housing, rounded arms with serrated tip | Identical |
| Number ofOpen-CloseCycles Prior toDeployment | 5 | 5 | Identical |
| HandleControlled ClipRotation | Yes | Yes | Identical |
| Introducer | |||
| WorkingLength | 230 cm | 230 cm | Identical |
| IntroducerDiameter(nominal) | 7 Fr | 7 Fr | Identical |
| MinimumWorkingChannel ofEndoscope | 2.8 mm for forward viewing endoscope, and4.2 mm for side viewing endoscope | 2.8 mm for forward viewing endoscope, and4.2 mm for side viewing endoscope | Identical |
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Cook Endoscopy – Special 510(k) Instinct Plus Endoscopic Clipping Device
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Cook Endoscopy – Special 510(k) Instinct Plus Endoscopic Clipping Device
Non-Clinical and/or Clinical Tests Summary and Conclusions:
Baseline testing consisting of non-clinical bench testing demonstrates that the Instinct Plus Endoscopic Clipping Device enabled consistent deployment of the clip to fulfill the intended use of the device. Validation testing was repeated to deploy devices without tissue to simulate worst case. Validation testing was also repeated utilizing process data to confirm the Strength of Distal Coil Cath Tabs met acceptance criteria. Testing passed demonstrating the device is substantially equivalent to the currently cleared predicate device.
§ 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.