(127 days)
The MananTM Nephrostomy Drainage Catheter is for percutaneous nephrostomy.
Manan drainage catheters are made from a biocompatible implantable urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in various end configurations: Locking pigtail-loop and non-locking pigtail. Also included with the catheters are stiffening cannulas.
The provided text describes a 510(k) submission for the Manan™ Nephrostomy Drainage Catheter. This is a premarket notification for a medical device seeking substantial equivalence to a predicate device, not a study describing its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the provided document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Not Available. The provided document is a 510(k) summary and FDA letter, which do not detail specific acceptance criteria or performance data from a new study. The submission relies on "substantial equivalence" to a predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Available. No new test set or study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Available. No new test set requiring expert ground truth is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Available. No new test set described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable/Not Available. The device is a physical drainage catheter, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Available. As above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable/Not Available. No new study is presented requiring a "ground truth." The submission relies on substantial equivalence to a legally marketed predicate device.
8. The sample size for the training set
- Not Applicable/Not Available. This is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable/Not Available. As above, no training set is relevant or described.
Summary of available information from the document:
- Device Name: Manan™ Nephrostomy Drainage Catheter
- Applicant: Medical Device Technologies, Inc.
- Common Name: Nephrostomy drainage catheter
- Classification Name: §878.4200-Introduction Drainage Catheter and Accessories
- Indications for Use: The Manan™ Nephrostomy Drainage Catheter is for percutaneous nephrostomy.
- Predicate Device: Manan Medical Products, Nephrostomy Drainage Catheter (510(k) No. K953547)
- Device Description: Made from biocompatible implantable urethane (Tecoflex) that softens at body temperature. Comes in various end configurations (locking pigtail-loop, non-locking pigtail) and includes stiffening cannulas.
- Regulatory Determination: The FDA determined the device is substantially equivalent to the predicate device.
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Image /page/0/Picture/1 description: The image shows the logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is in white text on a black background. The text is stacked, with MDTECH on top and MEDICAL DEVICE TECHNOLOGIES INC below.
11:14:14
MAY 2 7 1998
4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
510(k) SUMMARY
| APPLICANT: | Medical Device Technologies, Inc.4445-310 SW 35th TerraceGainesville, FL 32608 |
|---|---|
| CONTACT: | Karl SwartzQuality Assurance Manager |
| TELEPHONE: | (352)338-0440fax (352)338-0662 |
| TRADE NAMES: | MananTM Nephrostom |
| COMMON NAME: | Nephrostomy drainage catheter |
| CLASSIFICATION NAME: | §878.4200-Introduction Drainage Catheter and Accessories |
| SUBSTANTIAL EQUIVALENCE: |
| Company Name | Product Name | 510(k) No |
|---|---|---|
| Manan Medical Products | Nephrostomy Drainage Catheter | K953547 |
DESCRIPTION OF DEVICE:
Manan drainage catheters are made from a biocompatible implantable urethane (Tecoflex) that has been used extensively in both short and long term implantable medical devices. This material softens at body temperature thus minimizing tissue trauma. The catheters come in various end configurations: Locking pigtail-loop and non-locking pigtail. Also included with the catheters are stiffening cannulas.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 1998
Mr. Karl Swartz ·Ouality Manager Medical Device Technologies Incorporated 4445-310 South West 35th Terrace Gainesville, Florida 32608
K980192 Re: Manan™ Nephrostomy Drainage Catheter Trade Name: Requlatory Class: II Product Code: LJE Dated: April 16, 1998 Received: April 17, 1998
Dear Mr. Swartz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate able beated in the enoises, 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Swartz
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Colia M. Whitton, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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45-310 S.W. 35th Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Manan™ Nephrostomy Drainage Catheter
Indications for Use:
The Manan™ Nephrostomy Drainage Catheter is for percutaneous nephrostomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Divis.. Res Lative Dees
510(k) Numbe K980192
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
N/A