(423 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a simple mechanical rod, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used to temporarily keep a loop of the colon in place during ostomy surgery, which is a procedural aid, not a therapeutic treatment for a condition or disease.
No
The device description states its use is to keep a loop of the colon from slipping back through a surgical opening during an ostomy procedure. This is a surgical aid, not a diagnostic tool.
No
The device description clearly states it is a physical rod made of HDPE, a hardware component, and describes its physical characteristics and packaging.
Based on the provided information, the Coloplast Ostomy Rod is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used during a surgical procedure (loop ostomy surgery) to physically support a loop of the colon. It is a surgical aid.
- Device Description: The description details a physical rod made of HDPE, designed to be placed through tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are typically used in laboratories or point-of-care settings to analyze biological samples. The Coloplast Ostomy Rod is a surgical instrument used directly on the patient's body during a procedure.
N/A
Intended Use / Indications for Use
Coloplast Ostomy Rod is used for loop ostomy surgery. The ostomy rod is a device that is placed through a loop of the colon brought out through the abdominal wall to temporarily keep it from slipping back through the surgical opening during the loop (colostomy or ileostomy) ostomy procedure.
Coloplast Ostomy Rod is for use in loop ostomy surgery. The ostomy rod is a device that is placed through a loop of the colon brought out through the abdominal wall to temporarily keep it from slipping back through the surgical opening during the loop (colostomy) ostomy surgery.
Product codes (comma separated list FDA assigned to the subject device)
EZP
Device Description
The Coloplast Ostomy Rod is a 90mm white HDPE rod with a fixed T at one end and a separate T piece that can be snaoped into the open end of the rod once it is in place. Holes in the ends of the T allow for suturing. The device is packaged in a laminated polvethylene and cas-permeable paper pouch. The product is sterilized by irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colon
Indicated Patient Age Range
Not Found
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)
The Coloplast Ostomy Rod has been tested for tensile strength, flexural strength, The Colopiast Ostonly Rod has been testour testour wonitored through ongoing testing.
The Coloplast Ostomy Rod has been tested for biocompatibility, cytotoxicity, Trie Colopiast Ostomy Nod has bron 10993-01 Biological Evaluation of il htation and Sensitization do roquired by 100 - 100 all critieria for acceptance were met.
Leachable profiles were tested for two lots of ostomy rods one at baseline and one near expiration and there was no significant change associated with time.
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
§ 876.4270 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.
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page 1(3)
510(k) Summary
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:新闻
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Coloplast Ostomy Rod
| 1. Submitters name, address, phone and fax numbers | Coloplast Corp
1975 West Oak Circle
Marietta, GA 30062 - 2249
U.S.A.
Tel.: (770) 281 8400
Fax: (770) 281 8500 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Contact person at Coloplast Corp | Elizabeth Boots
BA, MT
Quality Assurance Vice President
Coloplast Corp, Skin Care Division
1940 Commerce Drive
P.O. Box 8300
N. Mankato, MN 56003 - 8300 U.S.A.
Tel.: (507) 386 4362
Cell: (507) 351 6750
Fax: (507) 345 3291
Email: usbb@coloplast.com |
| 3. Date that the 510 (k) summary was prepared | September 29, 2006 |
and the comments of the comments of
1
| 4. Name of the medical device (trade, common and classification | |
|---|---|
| name) | and the first to the state of the states |
| 12 11 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | |
| Trade name | Coloplast Ostomy Rod |
Loop Ostomy Rod Common Name
Classification name Rod. Colostomy
- Legally marketed device to which substantial equivalence is claimed
ConvaTec Sur-Fit System K811240
- Description of the device
The Coloplast Ostomy Rod is a 90mm white HDPE rod with a fixed T at one end and a separate T piece that can be snaoped into the open end of the rod once it is in place. Holes in the ends of the T allow for suturing. The device is packaged in a laminated polvethylene and cas-permeable paper pouch. The product is sterilized by irradiation.
7. Intended use of the device of
Coloplast Ostomy Rod is used for loop ostomy surgery. The ostomy rod is a device that is placed through a loop of the colon brought out through the abdominal wall to temporarily keep it from slipping back through the surgical opening during the loop (colostomy or ileostomy) ostomy procedure.
- Technological characteristics companson to the predicate device
The ConvaTec Sur-Fit System has a size range of 65-90 mm that incluces the 90mm size for the Coloplast Ostomy Rod.
The ConvaTec Sur-Fit System has a fixed triangular shaped in a T at one end and an adjustable position triangular T at the other end to allow the T to be swiveled after insertion. It may be sutured through the triangular shapes, but does not need to be.
The Coloplast Ostomy Rod has a fixed T on one end a second T piece that can be snapped onto the opposite end of the rod once it is in place. It may be sutured through holes in the ends of the T arms, but does not need to be. Both are produced by injection molding,
The Coloplast Ostomy Rod and the ConvaTec Sure-Fit System are labeled as sterile by irradiation and for single use only.
Flexural strength and flexibility were compared with results for the Coloplast Ostomy Rod and the Conva-Tec Sure-Fit System giving similar results both well above the estimated effect from the colon.
The Coloplast Ostomy Rod is made from HDPE. This is not the same material used for the ConvaTec Sure-Fit System, but is widely used in the medical industry and is shown to meet biocompatibility requirements.
2
9. Non-clinical performance data
The Coloplast Ostomy Rod has been tested for tensile strength, flexural strength, The Colopiast Ostonly Rod has been testour testour wonitored through ongoing testing.
The Coloplast Ostomy Rod has been tested for biocompatibility, cytotoxicity, Trie Colopiast Ostomy Nod has bron 10993-01 Biological Evaluation of il htation and Sensitization do roquired by 100 - 100 all critieria for acceptance were met.
Leachable profiles were tested for two lots of ostomy rods one at baseline and one near expiration and there was no significant change associated with time.
- Conclusion 1 3 % ( 1 % 1 % 1
The Coloplast Ostomy Rod is similar in size, construction and design to the ConvaTec Sur-Fit System. The intended uses and classifications are the same.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is written in a simple, sans-serif font.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Elizabeth Boots Vice President, Quality Assurance Coloplast Corporation 1940 Commerce Drive N MANKATO MN 56002-8300
OCT 1 3 2006
Re: K052229
Trade/Device Name: Coloplast Ostomy Rod, Model 12814 Regulation Number: 21 CFR §876.4270 Regulation Name: Colostomy rod Regulatory Class: II Product Code: EZP Dated: September 29, 2006 Received: October 3, 2006
Dear Ms. Boots:
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 (Premarket Approval); 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.
Image /page/3/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006". The letters "FDA" are prominently displayed in the center of the logo. The logo is surrounded by a circular border with additional text, though the specific words are difficult to discern due to the image quality. The overall design commemorates the centennial anniversary of the FDA.
Protecting and Promoting Public Health
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Page 2 -
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.
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 (31 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known): Not known
Device Name: Coloplast Ostomy Rod
Indications for Use:
Coloplast Ostomy Rod is for use in loop ostomy surgery. The ostomy rod is a device that is placed through a loop of the colon brought out through the abdominal wall to temporarily keep it from slipping back through the surgical opening during the loop (colostomy) ostomy surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
ﻟﻤﺴﺎ Prescription Use_ (Per 21 CFR 801.109
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David br. Heymann
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 51U(k) Number