(260 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of suture anchors and related components. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is intended for anchoring the abdominal wall or a hollow viscus prior to the introduction of interventional catheters, acting as a support structure rather than directly treating a disease or condition.
No
Explanation: The device is intended for anchoring purposes prior to the introduction of interventional catheters. It is a mechanical device used for
fixation, not for diagnosing a condition or disease.
No
The device description clearly details physical components made of stainless steel, suture material, and polyethylene tubing, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for physically anchoring tissues within the body (abdominal wall to a hollow viscus) to facilitate the introduction of catheters. This is an in vivo procedure, meaning it is performed within a living organism.
- Device Description: The device description details physical components like suture anchors, needles, wire guides, and dilators. These are all instruments used for surgical or interventional procedures performed directly on a patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status. IVDs typically involve reagents, assays, or analytical instruments used in a laboratory setting.
The device described is a surgical/interventional device used for a procedural purpose, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KGC
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 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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal wall, hollow viscus, stomach
Indicated Patient Age Range
Cope Pediatric Gastrointestinal Suture Anchor Set: infant, child, and adolescent populations.
Enterostomy Suture Anchor Set: child, adolescent, and adult populations.
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)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
Enclosure
3
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)
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.
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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4
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 Incorporated |
| 750 Daniels Way | |
| Bloomington, 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 Set
Enterostomy 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.
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
5
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.
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.
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.
6
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 Gastrointestinal | |
| Suture Anchor Set | Intended for anchoring the anterior wall of the stomach to 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 | |
| Enterostomy Suture Anchor Set | 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 |
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 Anchor
K873606 | Cope Pediatric Gastrointestinal
Suture Anchor Set
Subject Device | |
|-------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | Pre-Loaded | Un-Loaded |
| Regulation Number | 876.5010 | 876.5980 | |
| Product Code | FGE | KGC | |
| Classification | II | II | |
| Intended Use | Used for retaining hollow viscera
prior to introduction of interventional
catheters | Intended for anchoring the anterior wall of the
stomach to 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 | |
| Table 2 Substantial Equivalence Comparison Table - Cope Pediatric Gastrointestinal Suture Anchor Set |
|---|
7
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 Anchor
K873606 | | Cope Pediatric Gastrointestinal
Suture 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 loaded
in 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) | | | |
| | Proximal
suture needle | Yes | | No | | | |
| | Material,
needle | Stainless Steel | | Identical | | | |
| | Material, hub | Polycarbonate | | Polypropylene | | | |
| Introducer
needle | 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 | |
| Backload
needle | Distal tip | | | Blunt | | (the second anchor is
provided without
backload 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 securement
method | | Secured to skin | | Wrap the ends of the suture around gauze rolls and
secure in place | | | |
| Mode of operation | | Loaded anchor is deployed into the
stomach as the wire guide pushes it
from the proximal end of the
introducer needle. After the tract
formation, the anchor is removed by
cutting the suture and allow their
passage via the gastrointestinal
system. | | Identical | | | |
8
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 Anchor
K873606 | Cope Pediatric Gastrointestinal
Suture Anchor Set
Subject 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 Anchor
K873606 | Enterostomy Suture Anchor Set
Subject Device | | |
|--------|-------------------|----------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | Regulation Number | 876.5010 | 876.5980 | | |
| | Product Code | FGE | KGC | | |
| | Classification | II | II | | |
| | Intended Use | | Used for retaining hollow viscera prior to
introduction of interventional catheters | 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 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
9
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA PHONE: 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
| | | Modified Cope Suture Anchor
K873606 | | Enterostomy Suture Anchor Set
Subject Device | |
|-----------------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|-----------------------------------------------------------------------|--------|
| | Material | Polydek® suture | | Tevdek® suture | |
| | USP Size | 4-0 | | 5-0 | |
| | Length | 40 cm | | 30 cm | |
| | Count | 1 | | Identical (1 per anchor) | |
| Suture | Proximal
suture needle | Yes | | No | |
| | Material | Stainless Steel | | Stainless Steel | |
| | Material, hub | Polycarbonate | | Polycarbonate | |
| | Distal tip | Lancet | | Identical | |
| Introducer
needle | Dimensions | Diameter | Length | Diameter | Length |
| | | 18 G | 12 cm | 18 G | 7 cm |
| | Material | Not included | | Stainless Steel | |
| | Distal tip | Not included | | Blunt | |
| Backload
needle | 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 securement
method | | Secured to skin | | Wrap the ends of the suture around gauze
rolls and secure in place | |
| Mode of operation | | Loaded anchor is deployed into the
stomach with the wire guide from the
proximal end of the introducer needle.
After the tract formation, the anchor is
removed by cutting the suture and allow | | Identical | |
| | | their passage via the gastrointestinal
system. | | | |
| | 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).