(68 days)
The Perneczky Titanium Aneurysm Clips are devices used to occlude an intracranial aneurysm (a balloon like Sac formed on a blood vessel) to prevent it from bleeding or rebleeding. These clips are intended for use as temporary or permanent devices.
These titanium alloy aneurysm clips will be available as temporary or permanent in STANDARD OR MINI/ MICRO models.
The provided text is a 510(k) Premarket Notification for the Perneczky Titanium Aneurysm Clips. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed acceptance criteria table and the results of extensive clinical trials with specific performance metrics as would be found in a PMA (Premarket Approval) submission.
Therefore, the document does not contain the specific information requested regarding detailed acceptance criteria, a comprehensive study proving device performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance data, or ground truth details for testing and training sets.
However, I can extract information related to the demonstration of substantial equivalence if that would be helpful, as it is the primary focus of this type of submission. The document states that the device is substantially equivalent to legally marketed predicate devices, implying that its performance is expected to be similar.
Here's what can be inferred from the document regarding the basis for acceptance, which is "substantial equivalence":
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criterion Type: Substantial Equivalence to predicate devices.
- Performance (Implied): The new device's technological characteristics, material composition, and intended use are considered similar to those of the predicate devices, thereby implying comparable performance. The document explicitly states: "The additional patterns of Perneczky Titanium Alloy aneurysm clips do not incorporate any new technological characteristics when compared to Zeppelin's current Perneczky Titanium aneurysm clips, or to other legally marketed devices."
2. Sample size used for the test set and the data provenance:
- This information is not provided in the 510(k) summary. 510(k)s often rely on bench testing and comparisons to predicate devices rather than large-scale clinical trials for substantial equivalence.
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.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided.
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:
- This is not applicable as the device is a physical aneurysm clip, not an AI or imaging diagnostic tool that would involve "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical aneurysm clip.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not provided. The basis for equivalence relies on comparing the device's technical specifications and material properties against established standards and predicate devices.
8. The sample size for the training set:
- This information is not provided and is not applicable in the context of this type of device submission.
9. How the ground truth for the training set was established:
- This information is not provided and is not applicable in the context of this type of device submission.
Summary of Basis for Substantial Equivalence cited in the document:
- Technological Characteristics: The device "do not incorporate any new technological characteristics" compared to predicate devices.
- Material Composition: The material (titanium alloy Ti6AL4V) and its properties conform to ASTM International standards (e.g., F136-98 & F1472-98).
- Intended Use: The intended use "to occlude cerebral aneurysms in either a temporary or permanent manner" is consistent with predicate devices.
- Predicate Devices: The device is deemed equivalent to several existing aneurysm clips, including:
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มาราคลางอิง แบบแลนด์ เจ เข (ญ) รันมาแรงเขา บา Pemecky และแนท Aneurysm Ulps
NOV 2 6 2001
KO13136 PREMARKET NOTIFICATION [510(k)] SUMMARY
A. SUBMITTER INFORMATION:
establishment registration no .:
date of summary: submitted by:
11-04-00 VON ZEPPELIN CHIRURGISCHE INSTRUMENTE GMBH Gististrasse 99 82049 Pullach- Germany -Tel.: +49 / 89 / 7936880 Fax: +49 / 89 / 7938545 8010947 Mr. von Zeppelin, President
B. DEVICE INFORMATION
Perneczky Titanium Aneurysm Clips Trade Name Aneurysm Clips: see "Appendix 3"
Common Name:
contact person:
Class of Device:
Classification Name:
Equivalent Device:
"Aneurysm Clips"
Class II
Aneurysm Clip
Clips Yasargil Titanium Aneurysm (#K983758) by Aesculap Spetzler Ti 100 Aneurysm Clips (#K955064) bv Elekta Sugita Aneurysm clips (#K782040) by Down Surgical, by Mizuho Medical Codman occlusion clips (#K760771) such as Sundt-Kees Slim-Line Aneurysm Clips and McFadden Vari-Angle Aneurysm clips.
C. DEVICE DESCRIPTION:
These titanium alloy aneurysm clips will be available as temporary or permanent in STANDARD OR MINI/ MICRO models.
D. INTENDED USE OF DEVICE:
The intended use of the Perneczky Titanium Alloy aneurysm clips is to occlude cerebral aneurysms in either a temporary or permanent manner. They are applied by Zeppelin clip appliers.
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E. TECHNOLOGICAL CHARACTERISTICS
The additional patterns of Perneczky Titanium Alloy aneurysm clips do not The adultional patterns of 1 ornocity when compared to Zeppelin's Incorporate any new cennologiour characterism clips, or to other legally current Femeczky Titanium of marketed devices. The thanian and oney one onent Phynox and Titanium aneurysm clips.
F. MATERIAL COMPOSTION / BIOCOMPATIBILITY
The material composition is titanium alloy (Ti6AL4V). The alloy composition and The Thatehall Composition is thankam and (170) "Implants for Surgery Metallic propentes conformio with to Titanium 6-Aluminium 4-Vanadium Alloy" and ASTM Matenals - Frant of Vrrought Titanian for Wrought Titanium-6 Aluminium-4 Stardalum ELI (Extra Long Interstitial) Alloy (UNS R56401) for Surgical Implants Applications".
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 6 2001
Mr. Dieter von Zeppelin President von Zeppelin Chirurgische Instrumente GmbH Gistlstrasse 99 82049 Pullach / Germany
Re: K013136
Trade/Device Name: Perneczky Titanium Aneurysm Clips Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm Clip Regulatory Class: Class II Product Code: HCH Dated: August 23, 2001 Received: September 19, 2001
Dear Mr. von Zeppelin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass based in 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) that do not require approval of a premarket approval application (PMA). 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 (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Dieter von Zeppelin
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with and w you've begal finding of substantial equivalence of your device to a legally premarket notineation: "The President on 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 11 you desire specific art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 CFTC Far 807.10 Idditionally, for questions on the promotion and advertising of Compliance at (301) 597-1857 Fridates Compliance at (301) 594-4639. Also, please note the your device, prodo volinareading by reference to premarket notification" (21CFR Part 807.97). Ingulation onlined, "Nilostanang one responsibilities under the Act may be obtained from the Other general information of the mational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Walker, MD
$\ell$
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Page 1 of 1
K013138 510(k) Number (if known): _ Pemeczky Titanium Aneurysm Clips Device Name: _
Indications for Use:
The Perneczky Titanium Aneurysm Clips are devices used to occlude an intracranial The Pemeczky Titanium Aneurysin Clips are nessely to prevent it from bleeding or aneurysm (a balloon like Sac lonned on a blood vossaly to provide in the success or permanent devices.
(Signature)
Dieter von Zeppelin (Type Name)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use _
Susan Walker, m
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K013136
§ 882.5200 Aneurysm clip.
(a)
Identification. An aneurysm clip is a device used to occlude an intracranial aneurysm (a balloonlike sac formed on a blood vessel) to prevent it from bleeding or bursting.(b)
Classification. Class II (performance standards).