(19 days)
The Manan™ Manta Catheter Fixation Disk is intended for the fixation of percutaneous drainage catheters.
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.
The provided document is a 510(k) summary for the Manan™ Manta Catheter Fixation Disk, dated April 22, 1998. It primarily focuses on demonstrating substantial equivalence to a predicate device for market clearance. This type of regulatory submission in 1998 would typically not include the detailed performance study information requested in the prompt, especially not in the format of acceptance criteria tables, sample sizes for training/test sets, expert qualifications for ground truth, or discussions of AI algorithms and MRMC studies, as these concepts relate to more recent advancements in medical device evaluation, particularly for AI/ML devices.
Therefore, many of the requested data points (such as acceptance criteria, reported performance against those criteria, detailed study designs, ground truth methodologies, and AI-specific metrics) are not present in this document. The document confirms that the device is a simple mechanical fixation device, not an AI-powered diagnostic or therapeutic system.
Based on the provided text, here is what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not contain an explicit table of acceptance criteria or reported device performance for the Manan™ Manta Catheter Fixation Disk. The substantial equivalence determination is based on the device's similarity in design and intended use to a legally marketed predicate device (Manan Medical Products Manta Catheter Fixation Disk, 510(k) No. K954132), rather than performance against pre-defined quantitative acceptance criteria in a detailed clinical study.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. The document describes a substantial equivalence submission, not a performance study requiring a test set of data in the context of AI/ML or a detailed clinical trial. The device is a physical catheter fixation disk, and its evaluation would likely involve engineering tests (e.g., tensile strength, biocompatibility – not detailed here) and potentially limited human factors evaluations, but not a "test set" of patient data in the manner implied by the prompt.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This information pertains to performance studies for diagnostic or prognostic devices, particularly those involving image interpretation or complex data analysis. The Manan™ Manta Catheter Fixation Disk is a mechanical fixation device, and the concept of "ground truth" established by experts for a test set is not relevant to its regulatory submission as presented.
4. Adjudication Method for the Test Set:
Not applicable for the same reasons as above. Adjudication methods are relevant for resolving discrepancies in expert interpretations of data or outcomes in performance studies.
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. An MRMC study is used to evaluate the performance of diagnostic devices, often involving human readers and potentially AI assistance. This device is a mechanical catheter fixation device and does not involve "readers" or "AI assistance."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm and does not have standalone performance in the context of AI/ML systems.
7. The Type of Ground Truth Used:
Not applicable. The concept of "ground truth" as typically discussed in performance studies (e.g., pathology, outcomes data, expert consensus) is not directly relevant to the 510(k) submission for this mechanical device. The substantial equivalence is based on comparing the device's design, materials, and intended use to a predicate device.
8. The Sample Size for the Training Set:
Not applicable. Training sets are relevant for machine learning algorithms. This device is a physical product.
9. How the Ground Truth for the Training Set was Established:
Not applicable for the same reason.
Summary based on the document:
The Manan™ Manta Catheter Fixation Disk is a soft silicone device intended for the fixation of percutaneous drainage catheters. Its 510(k) submission (K981229) demonstrated substantial equivalence to a predicate device, the Manan Medical Products Manta Catheter Fixation Disk (K954132). The regulatory classification is Class II (21 CFR 876.5130/Procode: 78 KNY). The document does not provide details on specific performance studies with acceptance criteria, sample sizes, expert-established ground truth, or AI-related metrics because it is a submission for a mechanical device undergoing a substantial equivalence review, not an AI/ML device requiring a clinical performance study as described in the prompt.
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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
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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
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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)
§ 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.