The Cope Pediatic Gastrointestinal Suture Anchor Set is intended for anchoring the anterior wall of the abdominal wall prior to the introduction of interventional catheters and can stay in place for up to 14 days in infant, child, and adolescent populations.

The Enterostomy Suture Anchor Set is intended for anchoring the wall of a hollow viscus to the abdominal wall prior to the introduction of interventional catheters and stay in place for up to 14 days in child, adolescent, and adult populations.

Device Description

This bundled submission includes two devices: Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set. Both subject devices include two suture anchors that are identical.

The Cope Pediatric Gastrointestinal Suture Anchor Set is available in two set configurations. Both set configurations are supplied with two suture anchors that are identical. The first suture anchor is pre-loaded in the lancet-tip introducer needle. The second suture anchor may come pre-loaded in the blunt-tip backload needle. A wire guide is supplied if the second suture anchor comes pre-loaded in the backload needle. The suture anchor is made of a 0.025-inch stainless steel anchor and a 30-cm suture. The anchor is either 2 cm or 1.3 cm long. The suture is the 5-0 size Tevdek® and one end of the suture is bonded at the center of the anchor. The introducer needle is made of 19-gauge stainless steel cannula in the length of 7 cm. The distal tip of the introducer needle is lancet bevel. Similarly, the backload needle is made of 19-gauge stainless steel cannula and 3 cm long. The distal tip of the backload needle is blunt. The wire guide is made of 0.025-inch stainless steel coil and 80 cm in length. Again, the wire guide is only supplied in the set configuration that the suture anchor is pre-loaded in the introducer needle.

The Enterostomy Suture Anchor Set is supplied with two suture anchors, the lancet-tip introducer needle, the blunt-tip backload needle, the wire guide, and the dilator. The suture anchors are pre-loaded in the backload needle. The suture anchor is made of a 0.025-inch stainless steel anchor and a 30-cm suture. The suture is the 5-0 size Tevdek® and one end of the suture is bonded at the center of the anchor. The introducer needle is made of 18-gauge stainless steel cannula in the length of 7 cm. The distal tip of the introducer needle is lancet bevel. Similarly, the backload needle is made of 18-gauge stainless steel cannula and 5 cm long. The distal tip of the backload needle is blunt. The wire guide is made of 0.035-inch stainless steel coil and 80 cm in length. The wire guide is coated in polytetrafluoroethylene. The dilator is made of 8 French polyethylene tubing and 20 cm in length. The distal end of the dilator is tapered to 0.035 inches in diameter.

AI/ML Overview

This document is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding Cook Incorporated's Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of an AI/ML device.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types is not available within this document.

This document describes a medical device, not an AI/ML system. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility bench testing, not clinical performance or AI model validation.

Here's an breakdown of what is available and why the requested information for an AI/ML device is not applicable:

A table of acceptance criteria and the reported device performance:
- Not applicable for AI/ML performance. The document lists "Bench Testing (including time zero and applicable three year accelerated aged testing)" and "Biocompatibility Testing" as performed. These tests confirm design input requirements and biocompatibility, but no specific quantitative performance metrics (like accuracy, sensitivity, specificity for a diagnostic device) with corresponding acceptance criteria are provided in a table format. The conclusion states the device meets design input requirements, implying successful completion of these physical and biological tests.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for AI/ML performance. No "test set" in the context of observational data (e.g., medical images or patient records) is mentioned. The testing described is physical/chemical "Bench Testing" and "Biocompatibility Testing" on the device itself.
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):
- Not applicable for AI/ML performance. No ground truth establishment by medical experts is mentioned, as this is a physical medical device, not a diagnostic AI.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for AI/ML performance. No adjudication method for expert review of data is mentioned.
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-assisted diagnostic tool.
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.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable for AI/ML performance. The "ground truth" for this device would be its physical properties (e.g., tensile strength, dimensions) and biological compatibility, verified through laboratory testing against established engineering standards and biocompatibility guidelines (e.g., ISO 10993-1).
The sample size for the training set:
- Not applicable. This device does not involve a training set as it is not an AI/ML product.
How the ground truth for the training set was established:
- Not applicable. This device does not involve a training set.

In summary, the provided document is a regulatory approval (510(k) clearance) for a physical medical device. It demonstrates substantial equivalence to a predicate device based on similar intended use, technological characteristics, and a battery of engineering and biocompatibility tests. It does not contain information relevant to the performance evaluation of an AI/ML-driven medical device, which would require data sets, ground truth establishment, and statistical performance metrics.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 26, 2019

Cook Incorporated Rohini Patel. Ph.D. Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404

Re: K182832

Trade/Device Name: Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal Tube and Accessories Regulatory Class: II Product Code: KGC Dated: May 28, 2019 Received: May 30, 2019

Dear Rohini Patel:

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. However, you are responsible to determine that the medical devices you use as components in the Cope Pediatric Gastrointestinal Suture Anchor Set and the Enterostomy Suture Anchor Set have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.

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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 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 medical devices and radiation-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

Shani P. Haugen, Ph.D. Acting Assistant Division 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

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Enclosure

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Indications for Use

510(k) Number (if known) K182832

Device Name

Cope Pediatric Gastrointestinal Suture Anchor Set Enterostomy Suture Anchor Set

Indications for Use (Describe)

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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Image /page/4/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, smaller block letters. The red background is a rectangle with a diagonal cut on the bottom right.

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA ONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

510(k) Summary

K182832 Cope Pediatric Gastrointestinal Suture Anchor Set Enterostomy Suture Anchor Set 21 CFR §876.5010 Date Prepared: 24 June 2019

Submitted By:

Submission:	Traditional 510(k) Premarket Notification
Applicant:	Cook Incorporated
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact:	Rohini Patel
Email:	RegSubmission@CookMedical.com
Contact Phone Number:	(812) 335-3575 x104516
Contact Fax number:	(812) 332-0281

Device Information:

Trade Name:	Cope Pediatric Gastrointestinal Suture Anchor SetEnterostomy Suture Anchor Set
Regulation Name:	Gastrointestinal tube and accessories
Classification Regulation:	21 CFR §876.5980, Product Code KGC
Device Class:	Class II
Classification Panel:	Gastroenterology/Urology

Predicate Device:

The predicate device for the Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set is the Modified Cope Suture Anchor (K873606, Cook Incorporated) cleared on June 17, 1988.

Device Description:

This bundled submission includes two devices: Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set. Both subject devices include two suture anchors that are identical.

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Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The word "COOK" is in white, bold letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, bold letters on a red background.

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

second suture anchor may come pre-loaded in the blunt-tip backload needle. A wire guide is supplied if the second suture anchor comes pre-loaded in the backload needle. The suture anchor is made of a 0.025-inch stainless steel anchor and a 30-cm suture. The anchor is either 2 cm or 1.3 cm long. The suture is the 5-0 size Tevdek® and one end of the suture is bonded at the center of the anchor. The introducer needle is made of 19gauge stainless steel cannula in the length of 7 cm. The distal tip of the introducer needle is lancet bevel. Similarly, the backload needle is made of 19-gauge stainless steel cannula and 3 cm long. The distal tip of the backload needle is blunt. The wire guide is made of 0.025-inch stainless steel coil and 80 cm in length. Again, the wire guide is only supplied in the set configuration that the suture anchor is pre-loaded in the introducer needle.

Where Chait Enterostomy Suture Anchor Set is mentioned instead of Enterostomy Suture Anchor Set in the submission, the references are made to the identical product. The "Chait" naming convention is used in the internal purposes.

Indications for Use:

The Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set are used for anchoring the anterior wall of the hollow viscus to the abdominal walls for up to 14 days. The exact verbiage of the intended use can be found in Table 1.

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Image /page/6/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters, stacked on top of the word "MEDICAL" in white, block letters. The words are set against a red background. The logo is simple and modern.

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA HONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

	Intended Use
Cope Pediatric GastrointestinalSuture Anchor Set	Intended for anchoring the anterior wall of the stomach to the abdominalwall prior to the introduction of interventional catheters and can stay inplace for up to 14 days in infant, child, and adolescent populations
Enterostomy Suture Anchor Set	Intended for anchoring the wall of a hollow viscus to the abdominalwall prior to the introduction of interventional catheters and stay inplace for up to 14 days in child, adolescent, and adult populations

Table 1 Subject Device Intended Use

Comparison to Predicate Device:

The subject devices, Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set, and the predicate device, the Modified Cope Suture Anchor (K873606), are substantially equivalent in that these devices have similar intended use and technological characteristics and are identical in method of placement.

The anchor material, introducer needle cannula material, wire guide material, number of sutures per anchor, and mode of operation are identical between the subject device Cope Pediatric Gastrointestinal Suture Anchor Set and the predicate device Modified Cope Suture Anchor (K873606). The differences between the subject device and predicate device, including target patient population, suture materials and dimensions, anchor dimensions, number of anchors, inclusion of a backload needle, suture securement method, and indications for use verbiage, do not raise any new questions of safety and/or effectiveness. The substantial equivalence comparison of the subject device, Cope Pediatric Gastrointestinal Suture Anchor Set, and the predicate device, Modified Cope Suture Anchor Set, is provided in Table 2 below.

	Modified Cope Suture AnchorK873606	Cope Pediatric GastrointestinalSuture Anchor SetSubject Device
		Pre-Loaded	Un-Loaded
Regulation Number	876.5010	876.5980
Product Code	FGE	KGC
Classification	II	II
Intended Use	Used for retaining hollow visceraprior to introduction of interventionalcatheters	Intended for anchoring the anterior wall of thestomach to the abdominal wall prior to theintroduction of interventional catheters and canstay in place for up to 14 days in infant, child, andadolescent populations

Table 2 Substantial Equivalence Comparison Table - Cope Pediatric Gastrointestinal Suture Anchor Set

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MEDICAL

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

		Modified Cope Suture AnchorK873606		Cope Pediatric GastrointestinalSuture Anchor Set
				Pre-Loaded		Un-Loaded
Device Picture
	Material	Stainless Steel (T-302 or T-304)		Stainless Steel (T-304)
	Dimensions	Diameter	Length	Diameter	Length	Diameter	Length
Anchor		0.038 in	2 cm	0.025 in	2 cm	0.025 in	1.3 cm
	Count	1		2 (second anchor loadedin backload needle)		2 (1 anchor loaded,1 anchor un-loaded)
	Material	Polydek® suture		Tevdek® suture
	USP Size	4-0		5-0
Suture	Length	40 cm		30 cm
	Count	1		Identical (1 per anchor)
	Proximalsuture needle	Yes		No
	Material,needle	Stainless Steel		Identical
	Material, hub	Polycarbonate		Polypropylene
Introducerneedle	Distal tip	Lancet		Identical
	Dimensions	Diameter	Length	Diameter	Length	Diameter	Length
		18 G	12 cm	19 G	7 cm	19 G	7 cm
	Material	Not included		Stainless Steel		Identical
Backloadneedle	Distal tip			Blunt		(the second anchor isprovided withoutbackload needle)
	Dimensions			Diameter	Length
				19 G	3 cm
	Material	Stainless Steel (T-302 or T-304)		Stainless Steel (T-304)
Wire guide	Distal tip	Flexible		Flexible
	Coating	Not coated		Not coated		Not included
	Dimensions	Diameter	Length	Diameter	Length
		0.038 in	80 cm	0.025 in	80 cm
	Indwell period	10-14 days		Up to 14 days
Suture securementmethod		Secured to skin		Wrap the ends of the suture around gauze rolls andsecure in place
Mode of operation		Loaded anchor is deployed into thestomach as the wire guide pushes itfrom the proximal end of theintroducer needle. After the tractformation, the anchor is removed bycutting the suture and allow theirpassage via the gastrointestinalsystem.		Identical

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Image /page/8/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a darker red background.

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

	Modified Cope Suture AnchorK873606	Cope Pediatric GastrointestinalSuture Anchor SetSubject Device
		Pre-Loaded	Un-Loaded
Sterilization, SAL	ETO, 10-6	Identical	Identical
Packaging	Tyvek peel-open pouch	Identical	Identical

The anchor material, introducer needle material, wire guide material, number of sutures per anchor, and mode of operation are identical between the subject device Enterostomy Suture Anchor Set and the predicate device Modified Cope Suture Anchor (K873606). The differences between the subject device and the predicate device, including target patient population, suture materials and dimensions, anchor dimensions, number of anchors, introducer needle dimensions, inclusion of a backload needle, wire guide dimensions and coating, inclusion of a dilator, suture securement method, and indications for use verbiage do not raise any new questions of safety and/or effectiveness. The substantial equivalence comparison of the subject device, Enterostomy Suture Anchor Set, and the predicate device, Modified Cope Suture Anchor Set, is provided in Table 3 below.

		Modified Cope Suture AnchorK873606	Enterostomy Suture Anchor SetSubject Device
	Regulation Number	876.5010	876.5980
	Product Code	FGE	KGC
	Classification	II	II
	Intended Use		Used for retaining hollow viscera prior tointroduction of interventional catheters	Intended for anchoring the wall of a hollowviscus to the abdominal wall prior to theintroduction of interventional catheters andstay in place for up to 14 days in child,adolescent, and adult populations
	Device Picture		Image: Modified Cope Suture Anchor	Image: Enterostomy Suture Anchor Set
Anchor	Material	Stainless Steel (T-302 or T-304)		Stainless Steel (T-304)
	Dimensions	Diameter	Length	Diameter	Length
		0.038 in	2 cm	0.025 in	1.3 cm
	Count	1		2 (both anchors loaded in backload needle)

Table 3 Substantial Equivalence Comparison - Enterostomy Suture Anchor Set

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COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

		Modified Cope Suture AnchorK873606		Enterostomy Suture Anchor SetSubject Device
	Material	Polydek® suture		Tevdek® suture
	USP Size	4-0		5-0
	Length	40 cm		30 cm
	Count	1		Identical (1 per anchor)
Suture	Proximalsuture needle	Yes		No
	Material	Stainless Steel		Stainless Steel
	Material, hub	Polycarbonate		Polycarbonate
	Distal tip	Lancet		Identical
Introducerneedle	Dimensions	Diameter	Length	Diameter	Length
		18 G	12 cm	18 G	7 cm
	Material	Not included		Stainless Steel
	Distal tip	Not included		Blunt
Backloadneedle	Dimensions	Not included		Diameter	Length
				18 G	5 cm
	Material	Stainless Steel (T-302 or T-304)		Stainless Steel (T-304)
Wire guide	Distal Tip	Flexible		Identical
	Coating	Not coated		Polytetrafluoroethylene
	Dimensions	Diameter	Length	Diameter	Length
		0.038 in	80 cm	0.035 in	80 cm
	Material	Not included		Polyethylene
	Distal Tip	Not included		Tapered
Dilator	Dimensions	Not included		Diameter	Length
				8 Fr	20 cm
	Indwell period	10-14 days		Up to 14 days
Suture securementmethod		Secured to skin		Wrap the ends of the suture around gauzerolls and secure in place
Mode of operation		Loaded anchor is deployed into thestomach with the wire guide from theproximal end of the introducer needle.After the tract formation, the anchor isremoved by cutting the suture and allow		Identical
		their passage via the gastrointestinalsystem.
	One-time Use	Yes		Identical
	Sterilization, SAL	ETO, 10-6		Identical
Packaging		Tyvek peel-open pouch		Identical

Image /page/9/Picture/3 description: The image shows the logo for Cook Medical. The word "COOK" is in white, sans-serif, uppercase letters on a red background. Below "COOK" is the word "MEDICAL" in white, sans-serif, uppercase letters on a darker red background.

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Image /page/10/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, with a registered trademark symbol next to it. Below "COOK" is the word "MEDICAL" in white. Both words are set against a red background, with the bottom right corner of the red background cut off at an angle.

COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA NE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM

Technological Characteristics:

The subject devices, Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set, were subjected to the following applicable testing to assure reliable design and performance under the specified testing parameters:

Bench Testing (including time zero and applicable three year accelerated aged testing)

Visual Inspection, Compatibility, and Dimensional Verification Testing (Zero -Time and Accelerated Aged)
Tensile Testing (Time Zero and Accelerated Aged) -
-MR Testing (Time Zero)
Radiopacity Testing (Time Zero) -

Biocompatibility Testing:

Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, and material-mediated pyrogenicity, were performed on the subject device to ensure the biocompatibility of the subject device. Additional testing was performed on the suture anchors: testing for subacute/subchronic toxicity, genotoxicity, and implantation.

Sterility and Packaging

Finished Product Qualification Sterility, Bioburden, Endotoxin, and EO -Residual
Simulated Distribution Testing -

Conclusion:

The results of these tests confirm that the Cope Pediatric Gastrointestinal Suture Anchor Set and Enterostomy Suture Anchor Set meet the design input requirements based on the intended use and support the conclusion that this device does not raise new questions of safety or effectiveness and is substantially equivalent to the predicate device, the Modified Cope Suture Anchor (K873606, Cook Incorporated).

Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory 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 (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.