(47 days)
The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners is intended to affix the stomach to the anterior abdominal wall facilitating primary placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these T-Fasteners be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes.
The Kimberly-Clark Enteral Access Dilation System is intended to facilitate stoma tract dilation prior to placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these dilator be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes
Device 1: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy* T-Fasteners
Device 2: Kimberly-Clark Enteral Access Dilation System
The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners consists of an internal retention T-Bar and an external suture-lock retention bolster connected by a length of resorbable suture. The T-Bar end is loaded onto the slot of a safety needle.
The Kimberly-Clark Enteral Access Dilation System is a stoma dilator with a peel-away sheath composed of a series of HDPE (high density polyethylene) telescoping dilator sleeves. It is available in 5 terminal sizes from 16FR up to 24FR (every even size).
This submission, K093312, indicates that no clinical or non-clinical laboratory testing was required to determine substantial equivalence because the subject devices (Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners and Kimberly-Clark Enteral Access Dilation System) are identical to components of the predicate device (Kimberly-Clark Introducer Kits, K080253).
Therefore, the acceptance criteria and study detailed in your request (including reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) are not applicable to this 510(k) submission. The FDA granted clearance based on the devices being identical in design, materials, sizes, and intended use as components of an already cleared device, without requiring new performance studies.
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K093312
1662
510(k) Summary
| Preparation Date: | November 6, 2009 | |
|---|---|---|
| Applicant: | Kimberly Clark Corporation1400 Holcomb Bridge RoadRoswell, GA 30097 | DEC - 8 2009 |
| Contact Person: | Lester F. PadillaTel. No.: 678-352-6766Fax. No. 920-382-6682 | |
| Trade/Proprietary Name(s): | Device 1: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy* T-FastenersDevice 2: Kimberly-Clark Enteral Access Dilation System | |
| Common Name(s): | Device 1: Gastropexy DeviceDevice 2: Stoma Dilator | |
| Classification Name: | Gastrointestinal tube and accessories(21 CFR Part 876.5980, Product Code KGC) |
Legally Marketed Device to Which Substantial Equivalence is Claimed:
-
- Kimberly-Clark Introducer Kits (K080253)
Device Description(s):
- The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners consists of an 1. internal retention T-Bar and an external suture-lock retention bolster connected by a length of resorbable suture. The T-Bar end is loaded onto the slot of a safety needle.
-
- The Kimberly-Clark Enteral Access Dilation System is a stoma dilator with a peel-away sheath composed of a series of HDPE (high density polyethylene) telescoping dilator sleeves. It is available in 5 terminal sizes from 16FR up to 24FR (every even size).
Intended Use(s):
-
Gastrointestinal Anchor Set with Saf-T-Pexy* T-Fasteners; 1.
The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners is intended to affix the stomach to the anterior abdominal wall facilitating primary placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these T-Fasteners be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes. -
- Enteral Access Dilation System
The Kimberly-Clark Enteral Access Dilation System is intended to facilitate stoma tract dilation prior to placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these dilator be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes
- Enteral Access Dilation System
Summary of Technologies:
The technological characteristics (design, materials of construction, sizes) of the Gastrointestinal Anchor Set with Saf-T-Pexy* T-Fasteners and the Enteral Access Dilation System are identical to the predicate device.
Clinical and Non-Clinical Testing:
No Clinical or Non-clinical laboratory testing were not required to determine substantial equivalence since the subject devices are identical to the device components of the predicate device.
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K093312
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Conclusion:
The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners and the Kimberly-Clark Enteral Access Dilation System are substantially equivalent to the predicate devices, the Kimberly-Clark Introducer Kits (K080253) since the subject devices are identical to the components of the predicate device and there are no changes to the technological characteristics or intended uses of the devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like extensions, suggesting movement or flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Kimberly-Clark Corporation c/o Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747
DEC - 8 2009
Re: K093312
Trade/Device Name: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy" T-Fasteners; and, Kimberly-Clark Enteral Access Dilation System
Regulation Number: 21 CFR §876.5980
Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KGC Dated: November 19, 2009 Received: November 23, 2009
Dear Mr. Conry:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 -
Enclosure
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K093312
Device Name: Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-PexyTM T-Fasteners
Indications for Use:
The Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy™ T-Fasteners is intended to affix the stomach to the anterior abdominal wall facilitating primary placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes. It is recommended that these T-Fasteners be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulda Glenn
(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number J
Page 1 of 2
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zofz
Indications for Use
510(k) Number (if known): K093312_
Device Name: Kimberly-Clark Enteral Access Dilation System
Indications for Use:
The Kimberly-Clark Enteral Access Dilation System is intended to facilitate stoma tract dilation prior to placement of the Kimberly-Clark MIC and MIC-Key brand Enteral Feeding Tubes.
It is recommended that these dilator be used only with the Kimberly-Clark MIC and MIC-KEY brand Enteral Feeding Tubes
Prescription Use ﮯ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
Page 2 of 2
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices,
510(k) Number K093312
§ 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.