(471 days)
The Amplatz "GOOSE NECK" Microsnare is intended for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system and hollow viscus. This includes intravascular foreign objects such as coils, balloons, portions of catheter and/or guidewires misplaced during interventional radiological procedures within the peripheral, neuro and cardiovasculature.
The Amplatz Goose Neck MicroSnare (NEUROSnare) is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the cornary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
The Amplatz "GOOSE NECK" Microsnare is a percutaneous retrieval and manipulation device with a uniquely shaped retriever loop. The "GOOSE NECK" Microsnare component consists of a core wire, with the "beak-like" retriever loop mounted at a right angle to the axis of shaft at its distal tip. The device is primarily comprised of a nickel-titanium alloy allowing virtual kink-resistant performance during navigation and retrieval of a foreign object.
The provided text describes a 510(k) summary for the Amplatz "GOOSE NECK" Microsnare, intended for retrieving foreign bodies from the cardiovascular system and hollow viscus. However, the document does not contain details about specific acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth methodologies typically found in a clinical study report for proving device performance.
The text states:
- "The Amplatz "GOOSE NECK" Microsnare has successfully passed all functional and safety testing requirements."
- "The Amplatz "GOOSE NECK" Microsnare is deemed substantially equivalent to commercially available MICROVENA and Target Therapeutics Retrieval devices based on functional testing and published clinical experiences."
This indicates that the device's performance was evaluated, but the specifics of how it met acceptance criteria for a study are not provided. The 510(k) summary is generally a high-level overview for regulatory submission, not a detailed clinical study report.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based on the provided text, highlighting what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional testing requirements met | Successfully passed all functional and safety testing requirements. |
| Safety testing requirements met | Successfully passed all functional and safety testing requirements. |
| Substantial equivalence to predicate devices | Deemed substantially equivalent to commercially available MICROVENA and Target Therapeutics Retrieval devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "functional and safety testing requirements" and "published clinical experiences" but does not provide a sample size for any specific clinical or non-clinical test set.
- Data Provenance: Not specified. The data provenance (e.g., country of origin, retrospective/prospective) for the "functional and safety testing" or "published clinical experiences" is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The filing refers to "functional testing and published clinical experiences," but details on expert involvement in establishing ground truth are absent.
4. Adjudication method for the test set
- This information is not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- No. An MRMC comparative effectiveness study is not mentioned. The regulatory submission is based on "functional testing and published clinical experiences" and establishing substantial equivalence to predicate devices, not on a direct comparison of human readers with and without AI assistance (which is not applicable here as it's a device, not an AI).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the Amplatz "GOOSE NECK" Microsnare is a physical medical device, not an algorithm or AI. Its performance is inherent to the device's mechanical function, not an algorithm. The term "standalone" in this context typically refers to the performance of an AI model independently.
7. The type of ground truth used
- The document implies that the ground truth for performance was established through:
- Functional and Safety Testing: Likely determined by successful completion of engineering specifications, mechanical tests (e.g., kink resistance, retrieval force), and biocompatibility assessments, rather than clinical 'ground truth' in the sense of pathology or expert consensus on clinical findings.
- Published Clinical Experiences: This suggests that existing literature or previous clinical use of similar devices informed the understanding of desired performance, but specific ground truth definition for a study is not given.
8. The sample size for the training set
- Not applicable/Not provided. As a physical medical device, there isn't a "training set" in the context of machine learning or AI. If "training set" refers to pre-market testing (e.g., bench testing, animal studies), the sample size for such activities is not detailed in this summary.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there's no training set in the AI sense, this question doesn't apply. For the general device development, ground truth would be established through engineering specifications, successful mechanical performance benchmarks, and compliance with safety standards. Details of these are not provided.
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JUN 1 0 1998
510(k) SUMMARY
| SUBMITTER: | MICROVENA Corporation |
|---|---|
| CONTACT PERSON: | Ms. Christine M. BuschRegulatory Affairs Associate |
| DATE PREPARED: | February 13, 1997 |
| TRADE NAME: | Amplatz "GOOSE NECK" Microsnare |
| CLASSIFICATION NAME: | Catheter, Percutaneous 21 CFR 870.1250 |
| PRODUCT CODE: | 78 DQY |
| PREDICATE DEVICE(S): | Amplatz "GOOSE NECK" Microsnare (K925439)Target Therapeutics' Retrieval Device(s):Retriever-18 (K914067), Retriever-10 (K921649) |
| DEVICE DESCRIPTION: | The Amplatz "GOOSE NECK" Microsnare is a percutaneous retrieval and manipulation device with a uniquely shaped retriever loop. The "GOOSE NECK" Microsnare component consists of a core wire, with the "beak-like" retriever loop mounted at a right angle to the axis of shaft at its distal tip. The device is primarily comprised of a nickel-titanium alloy allowing virtual kink-resistant performance during navigation and retrieval of a foreign object. |
| INTENDED USE: | The Amplatz "GOOSE NECK" Microsnare is intended for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system and hollow viscus. This includes intravascular foreign objects such as coils, balloons, portions of catheter and/or guidewires misplaced during interventional radiological procedures within the peripheral, neuro and cardiovasculature. |
| FUNCTIONAL &SAFETY TESTING: | The Amplatz "GOOSE NECK" Microsnare has successfully passed all functional and safety testing requirements. |
| CONCLUSION: | The Amplatz "GOOSE NECK" Microsnare is deemed substantially equivalent to commercially available MICROVENA and Target Therapeutics Retrieval devices based on functional testing and published clinical experiences. |
* As defined per Stedman's Medical Dictionary, Twenty-Third Edition; page 1563: viscus, pl. viscera (vis'kus, vis'er-ah) [L. the soft parts, internal organs. VISC-] An organ of the digestive, respiratory, urogenital, and endocrine systems as well as the spleen, the heart and great vessels; hollow and multilayered walled organs studied in splanchology.
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Image /page/1/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its head turned to the right. The eagle's body is composed of three human profiles facing the same direction.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 10 1998
Ms. Doralie Poganski Neurovascular Project Manager Microvena Corporation 1861 Buerkle Road White Bear Lake, Minnesota 55110-5246
K970668 Re: The Amplatz "Goose Neck" MicroSnare Trade Name: (NEUROSnare) Regulatory Class: II DOY Product Code: Dated: March 13, 1998 Received: March 16, 1998
Dear Ms. Poqanski:
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 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. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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 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 requlations.
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Page 2 - Ms. Doralie Poganski
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,
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
2008-14-12
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510(k) Number (if known): ___ K970668
Device Name: The Amplatz "Goose Neck" MicroSnare (NEUROSnare)
Indications For Use:
The Amplatz Goose Neck MicroSnare (NEUROSnare) is intended for use in the retrieval and manipulation of atraumatic foreign bodies located in the cornary and peripheral cardiovascular system and the extra-cranial neurovascular anatomy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510 (k) Number K970668
Prescription Use (Per 21 CFR 801.109)
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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).