(84 days)
The Medi-tech® 4 and 5 French Nighthawk™ Flush Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
The Medi-tech 4 and 5 French Nighthawk Flush Angiographic Catheters are available in the following dimensions and tip taper configurations. The 4 F Nighthawk catheters are tapered at the tip to be compatible with 0.035" guidewires. The 5 F Nighthawk catheters have two tapered tip configurations to be compatible with 0.038" and 0.035" guide wires. The Nighthawk Flush catheters utilize common biocompatible materials. The Nighthawk catheter shaft is coextruded using Pebax combined with a radiopaque filler for the inner layer and Pebax with a radiopaque filler and colorant as the outer surface layer. The shaft provides a smooth surface to allow for dye flow and easy guide wire movement as well as stiffness and curve retention. The radiopaque materials are utilized in the shaft and tip to allow visualization of the catheter during the procedure. The catheter will be provided with sideholes and optional silicone coating applied to the exterior surface of the outer layer. The catheters utilize a polycarbonate hub and Pebax strain relief. The hub is molded to the proximal end of the catheter shaft. A tip straightener is included as an accessory to the Flush line of catheters. The devices will be provided sterile and are intended for one procedure use only.
The provided 510(k) document (K9716007) describes the Medi-tech® 4 and 5 F Flush Angiographic Catheters. This submission is for a medical device (angiographic catheter) and not for an AI/ML-based diagnostic device. Therefore, many of the requested criteria related to AI/ML device studies (such as sample size for test set and training set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this traditional medical device submission.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through functional (non-clinical) testing.
Here's an analysis based on the information provided, with an emphasis on what is applicable for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative table format suitable for performance metrics like sensitivity or specificity, as it's a physical device rather than a diagnostic algorithm. Instead, it refers to various functional tests. The reported performance is a qualitative statement of adequacy.
| Acceptance Criteria (Functional Test Type) | Reported Device Performance (as stated in document) |
|---|---|
| Pressure burst | Verified adequate for intended use |
| Tip bond tensile | Verified adequate for intended use |
| Dye flow | Verified adequate for intended use |
| Tip coefficient of friction | Verified adequate for intended use |
| Force transmitted by the catheter tip | Verified adequate for intended use |
| Radiopacity | Verified adequate for intended use |
| Torque | Verified adequate for intended use |
| Tip straightener peel-away force | Verified adequate for intended use |
| Particulate | Verified adequate for intended use |
| Silicone coating integrity | Verified adequate for intended use |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified quantitatively. The document states "Functional testing consisted of..." but does not provide the number of units tested for each functional test.
- Data Provenance: Not specified, but generally for physical device testing, the tests are conducted in a laboratory setting by the manufacturer (SCIMED Life Systems, Inc. in Maple Grove, Minnesota). These are generally prospective tests conducted specifically for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This pertains to AI/ML diagnostic devices where expert consensus is used to label data. For physical device functional testing, a "ground truth" in this sense isn't established by experts, but rather by standardized test methods or engineering specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is relevant for clinical studies or AI algorithm ground truth establishment, not for physical device functional testing.
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. This refers to studies involving human interpretation of diagnostic results, often with and without AI assistance. This device is a catheter used to deliver contrast media, not a diagnostic imaging AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to the performance of an AI algorithm; this is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the AI/ML context. For physical device testing, the "ground truth" or reference standard for acceptable performance is typically defined by engineering specifications, international standards (e.g., ISO), or established test methods designed to simulate intended use conditions. The document states "Test results verified that the 4 and 5 French Nighthawk Flush Angiographic Catheters are adequate for their intended use," implying compliance with such internal or external standards.
8. The sample size for the training set
- Not applicable. This is for AI/ML models.
9. How the ground truth for the training set was established
- Not applicable. This is for AI/ML models.
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K9716007
510(k) Notification Medi-tech® 4 and 5 F Flush Angiographic Catheters
Section 4
Summary of Safety and Effectiveness
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
General Provisions L
JUL 2 4 1997
| Submitter's Nameand Address | SCIMED Life Systems, Inc.One SCIMED PlaceMaple Grove, Minnesota 55311 |
|---|---|
| Contact Person | Angela Raun(612) 494-2456 |
| Classification Name | Diagnostic Intravascular Catheters(21CFR Part 870.1200) |
| Common or Usual Name | Angiographic Intravascular Catheter |
| Proprietary Name | Medi-tech® 4 and 5 French Nighthawk™Flush Angiographic Catheters |
| Name of Predicate Devices | Medi-tech® 4 and 5 F Imager™ TennisRacket™ Flush catheters |
III. Device Description
II.
The Medi-tech 4 and 5 French Nighthawk Flush Angiographic Catheters are available in the following dimensions and tip taper configurations. The 4 F Nighthawk catheters are tapered at the tip to be compatible with 0.035" guidewires. The 5 F Nighthawk catheters have two tapered tip configurations to be compatible with 0.038" and 0.035" guide wires.
| Model | Catheter ID (ins) | Final Tip ID (ins) | Available Lengths | Sideholes |
|---|---|---|---|---|
| 4 F Nighthawk Non-braided Flush | 0.040" | tapers to 0.038" | 65-100 cm | yes |
| 5 F Nighthawk Non-braided Flush | 0.049" | tapers to 0.038" | 65-100 cm | yes |
| 5 F Nighthawk Non-braided Flush | 0.049" | tapers to 0.041" | 65-100 cm | yes |
The Nighthawk Flush catheters utilize common biocompatible materials. The Nighthawk catheter shaft is coextruded using Pebax combined with a radiopaque filler for the inner layer and Pebax with a radiopaque filler and colorant as the outer surface layer. The shaft provides a smooth surface to allow for dye flow and easy
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Section 4
Summary of Safety and Effectiveness, cont.
guide wire movement as well as stiffness and curve retention. The radiopaque materials are utilized in the shaft and tip to allow visualization of the catheter during the procedure. The catheter will be provided with sideholes and optional silicone coating applied to the exterior surface of the outer layer.
The catheters utilize a polycarbonate hub and Pebax strain relief. The hub is molded to the proximal end of the catheter shaft. A tip straightener is included as an accessory to the Flush line of catheters. The devices will be provided sterile and are intended for one procedure use only.
IV. Intended Use
The Medi-tech 4 and 5 French Nighthawk Flush Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
v. Non-clinical Test Summary
Functional testing consisted of pressure burst, tip bond tensile, dye flow, tip coefficient of friction, force transmitted by the catheter tip, radiopacity, torque, tip straightener peel-away force, and particulate and verification of the silicone coating integrity. Test results verified that the 4 and 5 French Nighthawk Flush Angiographic Catheters are adequate for their intended use. The 4 and 5 French Nighthawk Flush Angiographic Catheters are considered substantially equivalent to angiographic catheters currently marketed by Medi-tech based on a comparison of the intended use, design and results of in-vitro testing and evaluation.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angela Raun Senior Regulatory Affairs Specialist Boston Scientific Corporation One. SCIMED Place Maple Grove, Minnesota 55311-1566
JUL 2 4 1997
Re: K971607 Trade Name: Medi-tech® and 5 French Nighthawk™ Flush Angiographic Catheters Regulatory Class: II Product Code: 74DQQ Dated: April 30, 1997 Received: May 1, 1997
Dear Ms. Raun:
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, labelinq, 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 Requlations, 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 Failure to comply with the GMP requlation may result in assumptions. 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.
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Paqe 2 - Ms. Anqela Raun
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Section 2
Indications for Use
510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________
Device Name: Medi-tech® 4 and 5 French Nighthawk™ Flush Angiographic Catheters ·······························································································
Indications for Use:
The Medi-tech® 4 and 5 French Nighthawk™ Flush Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over The Counter Use
(Optional Format 1-2-96)
Lynne a. Reamer
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
1607
510(k) Number _
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).