(64 days)
No
The device description and intended use describe a physical surgical device with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as an accessory used in ostomy procedures to retain an exteriorized loop of bowel and is used in conjunction with ostomy appliances for collecting feces. It does not exert a therapeutic effect on the body to treat or prevent a disease.
No
The device description indicates it is a physical device used to retain a loop of bowel during surgical procedures, and it is used in conjunction with ostomy appliances to collect feces. Its intended use is to facilitate a surgical procedure and manage its outcome, not to diagnose a condition or disease.
No
The device description clearly states it is constructed of physical materials (PVC tubing and couplings) and is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during a surgical procedure (loop ileostomy and loop colostomy) to support an exteriorized loop of bowel. This is a surgical aid, not a diagnostic test performed on samples in vitro (outside the body).
- Device Description: The description details a physical device made of PVC tubing and couplings, designed for mechanical support. It does not involve reagents, assays, or any components typically associated with diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- User and Setting: The intended user is a surgeon in a surgical setting, not a laboratory professional performing diagnostic tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Easy Loop does not fit this description.
N/A
Intended Use / Indications for Use
For use in loop ostomy abdominal surgery to prevent the 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.
The Easy Loop is indicated for use in abdominal surgical procedures generally referred to as loop ileostomy and loop colostomy, where a loop of bowel is pulled through an abdominal incision and retained outside the body. The Easy Loop, which retains 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.
Product codes
EZP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity / loop of bowel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Board Certified Colon and Rectal Surgeons
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAR 2 4 2004
K040110
510(K) SUMMARY (Section E)
| 1. | Submitted by: | Tools for Surgery, LLC |
|---|---|---|
| 2. | Address: | 1339 Stony Brook Road |
| Stony 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. |
-
- 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.
-
- 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.
-
- 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.
1
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.
2
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
3
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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