(16 days)
Not Found
No
The summary describes a physical drainage catheter made of urethane and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is a drainage catheter used for percutaneous nephrostomy and abscess drainage, which are therapeutic procedures to remove fluid from the body.
No
The device is described as a "drainage catheter" used for percutaneous nephrostomy and abscess drainage, which are therapeutic procedures, not diagnostic ones. Its purpose is to drain fluids, not to identify or characterize medical conditions.
No
The device description clearly states it is a physical catheter made from urethane, which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Manan™ Malecot Basket Drainage Catheter is a device that is inserted into the body (percutaneously) for drainage purposes. It is a therapeutic and procedural device, not a diagnostic one that analyzes samples.
- Intended Use: The intended use clearly states "for percutaneous nephrostomy and abcess drainage," which are procedures performed directly on the patient's body.
The information provided about the device's material, configuration, and included components further supports that it is a physical device for drainage, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Manan™ Malecot Basket Drainage Catheter is for percutaneous nephrostomy and abcess drainage.
Product codes
78 FEW
Device Description
Manan drainage catheters are made from a biocompatible 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 malecot end configuration. Also included with the catheters are flexible stiffening cannula.
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
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. 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
P / 9 /
1981258
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 Terrace
Gainesville, FL 32608 |
|----------------------|----------------------------------------------------------------------------------------|
| CONTACT: | Karl Swartz
Quality Assurance Manager |
| TELEPHONE: | (352)338-0440
fax (352)338-0662 |
| TRADE NAMES: | Manan™™ Malecot Basket Drainage Catheter |
| COMMON NAME: | Suprapubic urological catheter |
| CLASSIFICATION NAME: | §876.509-Suprapubic Urological Catheter and Accessories |
SUBSTANTIAL EQUIVALENCE:
| Company Name | Product Name | 510(k) No. |
|---|---|---|
| Manan Medical Products | Malecot Basket Drainage Catheter | K954147 |
DESCRIPTION OF DEVICE:
Manan drainage catheters are made from a biocompatible 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 malecot end configuration. Also included with the catheters are flexible stiffening cannula.
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features the department's emblem, which is a stylized representation of a human figure. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 22 1998
Mr. Karl Swartz Quality Manager Medical Device Technologies, Inc. 4445-310 S.W. 35th Terrace Gainesville, FL 32608
Re: K981258 Manan™ Malecot Basket Drainage Catheter Dated: December 29, 1997 Received: April 6, 1998 Regulatory Class: II 21 CFR 876.5090/Procode: 78 FEW
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 ether 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 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 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 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) 594-4613. 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/odrh/dsmaldsmamain.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 black and white and features the letters "MDTECH" in a bold, sans-serif font. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller font. The logo is simple and modern, and it conveys a sense of professionalism and innovation.
4445-310 S.W. 35th Te Gainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Manan™ Malecot Basket Drainage Catheter
Indications for Use:
The Manan™ Malecot Basket Drainage Catheter is for percutaneous nephrostomy and abcess drainage.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert P. Rathbun
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K981258
Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)