(19 days)
No
The device description and intended use are purely mechanical and do not mention any computational or analytical functions. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
Explanation: The device is intended for fixation of percutaneous drainage catheters, which is a supportive rather than a therapeutic function. It does not directly treat or cure a disease or condition.
No
The device is described as a fixation disk for percutaneous drainage catheters, designed to secure a catheter to the skin, not to diagnose a condition or disease.
No
The device description explicitly states it is made of soft silicone and is sutured or adhered to the skin, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "fixation of percutaneous drainage catheters." This is a physical function performed on the body to secure a medical device.
- Device Description: The description details a physical device made of silicone that is sutured or adhered to the skin and holds a catheter.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples from the human body (blood, urine, tissue, etc.).
- Providing information about a patient's health status, diagnosis, or treatment based on sample analysis.
- Any laboratory or analytical procedures.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Manan Manta Catheter Fixation Disk does not perform any of these functions. It is a physical accessory used to secure another medical device.
N/A
Intended Use / Indications for Use
The Manan™ Manta Catheter Fixation Disk is intended for the fixation of percutaneous drainage catheters.
Product codes
78 KNY
Device Description
The Manan Manta Catheter Fixation Disk is made of soft silicone. It is sutured or adhered to the skin and a drainage catheter is snapped into the device. A nylon tie-wrap is used to secure the catheter into the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MDTECH
MEDICAL DEVICE TECHNOLOGIES INC.
APR 22 1998
510(k) SUMMARY
445-310 S.W. 35th Ter Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
p l g l
Medical Device Technologies, Inc. APPLICANT: 4445-310 SW 35th Terrace Gainesville, FL 32608 CONTACT: Karl Swartz Quality Assurance Manager TELEPHONE: (352)338-0440 fax (352)338-0662 Manan™ Manta Catheter Fixation Disk TRADE NAMES: COMMON NAME: Catheter anchoring or fixation device. CLASSIFICATION NAME: §846.5010-Biliary Catheter and Accessories SUBSTANTIAL EQUIVALENCE: Company Name Product Name 510(k) No.
DESCRIPTION OF DEVICE:
Manan Medical Products
The Manan Manta Catheter Fixation Disk is made of soft silicone. It is sutured or adhered to the skin and a drainage catheter is snapped into the device. A nylon tie-wrap is used to secure the catheter into the device.
Manta Catheter Fixation Disk
Group of companies A member of The
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human figures in profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 22 998
Mr. Karl Swartz Quality Manager Medical Device Technologies, Inc. 4445-310 S.W. 35th Terrace Gainesville, FL 32608
Re: K981229
Manan™ Manta Catheter Fixation Disk Dated: December 29, 1997 Received: April 3, 1998 Regulatory Class: II 21 CFR 876.5130/Procode: 78 KNY
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 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). 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 (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 requirements, as set forth in the Quality System Regulation (OS) 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 regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.
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 tegally 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) 594-4613. 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/dsmarain.html".
Sincerely yours
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for MDTECH Medical Device Technologies Inc. The logo is in a black box with rounded corners. The text "MDTECH" is in large, bold, white letters, and the text "MEDICAL DEVICE TECHNOLOGIES INC" is in smaller, white letters below the main text.
445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
510(k) Number (if known):_ K95 1209
Device Name: Manan™ Manta Catheter Fixation Disk
Indications for Use:
The Manan™ Manta Catheter Fixation Disk is intended for the fixation of percutaneous drainage catheters.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) な ber R D (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 481229 510(k) Number Prescription Use OR Over-The-Counter Use_
(Per 21 CFR 801.109)
(Optional Format 1-2-96)