EASY LOOP, MODEL EZL-01

K040110 · Tools For Surgery, LLC · EZP · Mar 24, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040110
• Device Name: EASY LOOP, MODEL EZL-01
• Applicant: Tools For Surgery, LLC
• Product Code: EZP · Gastroenterology, Urology
• Decision Date: Mar 24, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4270
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Easy Loop is indicated for use in abdominal surgical procedures generally referred the Lady Loop is mare specifically referred to as loop ileostomy and loop colostomy, where a loop of bowel is pulled through an abdominal incision and retained colosiony, which a loop of bonet to pair in paints the exteriorized loop of bowel from retracting back into the abdominal cavity, is used in conjunction with commercially available ostomy appliances which collect the evacuated feces.

Device Story

Easy Loop is a colostomy rod used during loop ostomy surgery. Device consists of 8-inch flexible PVC tubing with arrow-shaped slotted PVC couplings at each end. Surgeon inserts device through the mesentery of the exteriorized bowel loop; couplings interlock to form a closed loop, preventing bowel retraction into the abdominal cavity. Used in conjunction with standard wafer and pouch ostomy appliances. Operated by surgeons in clinical/surgical settings. Benefits patient by maintaining bowel exteriorization during the post-operative period.

Clinical Evidence

No clinical data provided. Safety and effectiveness were established based on successful employment by Board Certified Colon and Rectal Surgeons and comparison of technological characteristics to the predicate device.

Technological Characteristics

Constructed of 8-inch long, 0.28-inch diameter flexible PVC tubing. Features two 1.45-inch arrow-shaped slotted PVC coupling members at ends for interlocking. Mechanical retention device; no energy source or software.

Indications for Use

Indicated for patients undergoing loop ileostomy or loop colostomy procedures requiring retention of an exteriorized loop of bowel to prevent retraction into the abdominal cavity.

Regulatory Classification

Identification

A colostomy rod is a device used during the loop colostomy procedure. A loop of colon is surgically brought out through the abdominal wall and the stiff colostomy rod is placed through the loop temporarily to keep the colon from slipping back through the surgical opening.

Special Controls

*Classification.* Class II (special controls). 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.

Predicate Devices

• Loop Ostomy Rod (K830945)

Submission Summary (Full Text)

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MAR 2 4 2004

## K040110

## 510(K) SUMMARY (Section E)

| 1. | Submitted by: | Tools for Surgery, LLC |
|----|------------------------|------------------------------------------------------|
| 2. | Address: | 1339 Stony Brook Road<br>Stony Brook, New York 11790 |
| 3. | Telephone: | [phone] |
| 4. | Fax: | [phone] |
| 5. | Contact Person | Arnold R. Leiboff, M.D. |
| 6. | Date Summary Prepared: | January 6, 2004 |
| 7. | Device Trade Name: | Easy Loop |
| 8. | Common Name: | Colostomy Rod or Loop Ostomy Rod |
| 9. | Classification Name: | Rod, Colostomy. |

- 10. Substantial Equivalency is claimed against the following device: "Loop Ostomy Rod" manufactured by Convatec, a division of Bristol-Myers Squibb Co. of Skillman, NJ; 510(K) #K830945.
- 11. Description of the Device: The Easy Loop is constructed of an eight inch long x 0.28" diameter PVC flexible tubing, to which is bonded at each end a 1.45" long generally arrowshaped slotted PVC coupling member whose shape allows easy passage through the mesentery for placement of the device while resisting unintended withdrawal , and whose shape and slots permit interlocking of the two ends of the device to form a closed loop around the exteriorized loop of bowel.
- Intended use of the device: For use in loop ostomy abdominal surgery to prevent the 12. exteriorized loop of bowel of any caliber (diameter) from retracting into the body. The device is used in conjunction with any of the commercially available wafer and pouch component ostomy appliances.
- Safety and effectiveness of this device: This device has been successfully employed by 13. Board Certified Colon and Rectal Surgeons and was found to be as safe and effective as the predicate device cited above. See tabulated comparisons (paragraph 14 below) to further validate this claim.
- 14. Summary comparing technological characteristics with the predicate device: Please find a tabulated comparison supporting that this device is substantially equivalcnt to the predicate device in commercial distribution.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a stylized eagle.

Public Health Service

MAR 2 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Arnold R. Leiboff, M.D. President Tools for Surgery, LLC 1339 Stony Brook Road Stony Brook, New York 11790

Re: K040110

Trade/Device Name: Easy Loop, Model #EZL-01 Regulation Number: 21 CFR 876.4270 Regulation Name: Colostomy rod Regulatory Class: II Product Code: EZP Dated: January 6, 2004 Received: January 20, 2004

Dear Dr. Leiboff:

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 such 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); 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.

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Page 2 - Arnold R. Leiboff, M.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Easy Loop is indicated for use in abdominal surgical procedures generally referred the Lady Loop is mare specifically referred to as loop ileostomy and loop colostomy, where a loop of bowel is pulled through an abdominal incision and retained colosiony, which a loop of bonet to pair in paints the exteriorized loop of bowel from retracting back into the abdominal cavity, is used in conjunction with commercially available ostomy appliances which collect the evacuated feces.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K040110 510(k) Number_

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