(64 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called "Easy Loop" and does not contain information about explicit acceptance criteria or a detailed study proving its performance against such criteria. Instead, it claims substantial equivalence to a predicate device.
Here's an analysis based on the provided text, addressing your points where possible, and noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission claims substantial equivalence to a predicate device rather than presenting specific performance metrics against pre-defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document states that the device "has been successfully employed by Board Certified Colon and Rectal Surgeons," but it does not specify what constitutes this "successful employment," the number of cases, or the nature of any "test set." The data provenance is also not specified beyond the implicit use in a clinical setting by surgeons. It's likely retrospective observation rather than a structured prospective study for the purpose of this 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The document mentions that Board Certified Colon and Rectal Surgeons "found [the device] to be as safe and effective as the predicate device," but it doesn't detail how many surgeons were involved in this assessment or what specific "ground truth" they were establishing beyond a general assessment of safety and effectiveness.
4. Adjudication Method for the Test Set
This information is not provided. Given the lack of a structured "test set" and a formal evaluation method described, an adjudication method would not be applicable here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done or at least not described in this document. The submission is based on a claim of substantial equivalence to a predicate device, not on a comparative study with human readers (surgeons in this context) and AI. This device is a physical medical instrument, not an AI/software device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The "Easy Loop" is a physical medical device (a colostomy rod), not an algorithm or software. Therefore, a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
The ground truth implicitly used for the claim of safety and effectiveness appears to be expert opinion/clinical experience of Board Certified Colon and Rectal Surgeons. They deemed the device "as safe and effective as the predicate device," indicating an observational, real-world assessment by qualified professionals. There's no mention of pathology, objective outcomes data, or a controlled study to establish a formal "ground truth."
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device.
Summary of Device Rationale and "Proof" of Meeting Acceptance Criteria (as per the document):
The submission argues for substantial equivalence by comparing the technological characteristics of the Easy Loop with a legally marketed predicate device (Loop Ostomy Rod by Convatec, 510(K) #K830945). The "proof" relies on:
- Clinical Experience/Expert Opinion: "This device has been successfully employed by Board Certified Colon and Rectal Surgeons and was found to be as safe and effective as the predicate device cited above."
- Tabulated Comparison of Technological Characteristics: The document states, "Please find a tabulated comparison supporting that this device is substantially equivalent to the predicate device in commercial distribution." (The table itself is not included in the provided text snippets but is referenced as being part of the original submission).
Essentially, the "acceptance criteria" were met by demonstrating that the Easy Loop is sufficiently similar in design, materials, and intended use to a previously approved device, and that clinical experience with it supports its equivalence in safety and effectiveness when compared to the predicate, according to Board Certified Colon and Rectal Surgeons. No specific quantitative performance metrics or formal study results are presented in these excerpts.
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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 RoadStony Brook, New York 11790 |
| 3. | Telephone: | (631) 751-6930 |
| 4. | Fax: | (631) 751-6932 |
| 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. |
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- 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.
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- 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.
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- 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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_
Page 1 of _1
§ 876.4270 Colostomy rod.
(a)
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.(b)
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.