(56 days)
The NeoMed Urinary Catheter is intended for use in neonatal and pediatric patients to sample urine and/or facilitate urinary drainage. This catheter is NOT a Foley (balloon) type catheter. This catheter is intended for temporary use and will be in contact with the patient for less than 30 days.
The NeoMed Urinary Catheter is a silicone single lumen catheter that is used to drain urine. The device consists of the following main components: a single lumen urinary catheter, a hub, and a luer lock connector. It is available with either an orange radiopaque stripe or a natural white stripe (supplied from the barium sulfate loaded in the catheter).
The provided text describes the NeoMed Urinary Catheter and its clearance for market based on substantial equivalence to a predicate device, the CATCO Urological Catheter (K944782). The key information for acceptance criteria and the supporting study is:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the acceptance criteria and performance based on equivalence to the predicate device.
| Acceptance Criteria | Reported Device Performance Statement |
|---|---|
| Method of Operation | Same method of operation as predicate: drainage of urine through a single lumen catheter. |
| Functional Equivalence | Bench testing demonstrated functional equivalence to predicate and other urinary catheters. |
| Safety and Effectiveness | Minor differences do not affect safety or effectiveness. |
| Biocompatibility | Materials have a long history of use in catheter and urethral catheter manufacture and are biocompatible. |
| Intended Use Performance | Performs its intended use of urine drainage. |
| Duration of Contact | Intended for temporary use (< 30 days). |
| Patient Population | Intended for neonatal and pediatric patients. |
| Catheter Type | NOT a Foley (balloon) type catheter. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "Bench testing has demonstrated that the NeoMed Urinary Catheter is functionally equivalent to predicate urinary catheters". However, it does not specify the sample size for this bench testing. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) of this testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for a test set. The evaluation relies on functional equivalence to a predicate device.
4. Adjudication Method for the Test Set:
An adjudication method is not described as the evaluation is based on bench testing for functional equivalence rather than clinical studies requiring expert review or consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done or mentioned. The submission is focused on substantial equivalence through bench testing, not on comparing the device's effectiveness assisted by AI with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This device is not an AI algorithm. It is a physical medical device (urinary catheter). Therefore, a standalone performance study in the context of AI is not applicable and was not done.
7. The Type of Ground Truth Used:
The ground truth or basis for evaluation is the performance and characteristics of the predicate device (CATCO Urological Catheter, K944782) and other currently marketed urinary catheters. The device's performance is gauged against established functional criteria for such catheters and their known biocompatibility.
8. The Sample Size for the Training Set:
This device is a physical medical device, not an AI model. Therefore, the concept of a "training set" is not applicable in this context and no information is provided.
9. How the Ground Truth for the Training Set Was Established:
As this is not an AI model, the concept of a training set and its ground truth is not applicable. The device's design and manufacturing are based on established engineering principles and materials used in similar predicate devices.
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Image /page/0/Picture/1 description: The image shows the text "NEOMED incorporated". The text is written in a stylized font, with the letters appearing to be slightly faded or distressed. The word "NEOMED" is written in larger letters than the word "incorporated", which is placed below it. The overall impression is that of a logo or brand name.
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | NeoMed507 Hickory Ridge TrailSuite 120Woodstock, GA 30188Tony Lair, PresidentTel: 770-516-2225Fax: 770-516-2448e-mail: lair1@concentric.net | DEC 1 9 2007 |
|---|---|---|
| OFFICIALCORRESPONDENT | Penny Northcutt, RAC, CQARegulatory Consultant for NeoMed, Inc.REGSolutions, LLCTel: 678-428-6978Fax: 678-513-0937e-mail: pennynorthcutt@theregsolutions.com | |
| TRADE NAME: | NeoMed Urinary Catheter | |
| CLASSIFICATIONNAME: | Urethral Catheter, Urological catheter and accessories | |
| DEVICECLASSIFICATIONAND PRODUCTCODE | Class II per 21 CFR §876.5130Product Code: 78 GBM | |
| PREDICATEDEVICE NAME | CATCO Urological Catheter (K944782) |
SUBSTANTIAL EQUIVALENCE:
The NeoMed Urinary Catheter is substantially equivalent to the CATCO Urological Catheter cleared under K944782.
Both devices have the same method of operation, drainage of urine through a single lumen catheter. Bench testing has demonstrated that the NeoMed Urinary Catheter is functionally equivalent to predicate urinary catheters currently on the market and that any minor differences do not affect safety or effectiveness.
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DESCRIPTION OF THE DEVICE:
The NeoMed Urinary Catheter is a silicone single lumen catheter that is used to drain urine.
The device consists of the following main components: a single lumen urinary catheter, a hub, and a luer lock connector. It is available with either an orange radiopaque stripe or a natural white stripe (supplied from the barium sulfate loaded in the catheter).
INDICATIONS FOR USE:
This product is intended for use in neonatal and pediatric patients to sample urine and/or facilitate urinary drainage. This catheter is NOT a Foley (balloon) type catheter. This catheter is intended for temporary use and will be in contact with the patient for less than 30 days.
PERFORMANCE DATA:
The NeoMed Urinary Catheter materials that come in direct contact with the patient have a long history of use in catheter and urethral catheter manufacture and are biocompatible. Functional test results demonstrate that the NeoMed Urinary Catheter performs its intended use of urine drainage and is equivalent to the predicate device.
CONCLUSION:
Based on the performance testing, it can be concluded that the NeoMed Urinary Catheter is equivalent to the predicate CATCO Urological Catheter with respect to intended use and technological characteristics.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure with three arms or wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
C 1 9 2007
NeoMed. Inc. % Ms. Penny Northcutt Executive Director REGSolutions. LLC 717 Lakeglen Drive SUWANEE GA 30024
Re: K072997
Trade/Device Name: NeoMed Urinary Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD and GBM Dated: October 22, 2007 Received: October 24, 2007
Dear Ms. Northcutt:
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.
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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 (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Confidential
510(k) Number (if known):
Device Name: NEOMED URINARY CATHETER
Indications for Use:
The NeoMed Urinary Catheter is intended for use in neonatal and pediatric patients to sample urine and/or facilitate urinary drainage. This catheter is NOT a Foley (balloon) type catheter. This catheter is intended for temporary use and will be in contact with the patient for less than 30 days.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal and | ||
| Radiological Devices | ||
| 510(k) Number | K672997 | |
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | ||
| Traditional 510(k) | NeoMed Urinary Catheter | |
| NeoMed, Inc. | Confidential |
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§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.