(210 days)
Permanent placement in the brain for occlusion of cerebral aneurysms. They are only to be applied with PSI clip appliers with titanium alloy jaw inserts
Bent titanium wire which provides a spring operated, self Closing aneurysm clip of various lengths/sizes.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PSI Titanium Aneurysm Clip:
It's important to note that the provided documents (K991959 510(k) Summary and FDA clearance letter) are for a legacy device that was cleared in 2000. The regulatory requirements for device clearance, particularly regarding the rigor of performance studies and detailed reporting of clinical evidence, have evolved significantly since that time. Therefore, the level of detail regarding acceptance criteria and study methodology is much less than what would be expected for a modern submission.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific numerical acceptance criteria and a detailed table of performance are not explicitly stated in the modern format of performance goals (e.g., sensitivity, specificity, accuracy thresholds). Instead, the performance claims are qualitative and comparative to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Compatibility/Safety: Conformity to established standards for implantable titanium alloys. | Manufactured from titanium alloy (Ti-6Al-4V) conforming to ISO Standard 5832/3 and ASTM Standard F-136. |
| Functional Equivalence: Performs similarly to predicate devices in occluding cerebral aneurysms. | "functions in the same manner as the predicate device in the occlusion of cerebral aneurysms." When used with appropriate applier. |
| Dimensional Equivalence: Similar specifications to predicate devices. | "manufactured... to equivalent functional and dimensional specifications as the predicate clips." "share similar tolerances." |
| MRI Compatibility/Reduced Artifacts: Safe in MRI environment and provides reduced image artifacts. | "presents no additional risk to the patient or other personnel, is compatible with current diagnostic imaging equipment and provides substantially reduced image artifacts over cobalt-based predicate clips." |
| Safety and Effectiveness: Safe and effective for intended use. | "The Titanium Aneurysm Clip is safe and effective for it's intended use and meets all regulatory requirements to be found substantially equivalent to the predicate device." (This is a conclusion statement rather than a specific performance metric, typical of historical 510(k) summaries for substantial equivalence). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a test set or data provenance in the context of a clinical study or a statistically powered performance evaluation as would be expected today. The "Performance Data" section describes the device's functional and MRI characteristics, likely derived from bench testing, material characterization, and possibly comparison of existing literature or specifications of predicate devices. There is no mention of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided as there is no mention of a human-read test set or an expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a human-read test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted or described. This type of study, especially with "AI assistance," is a modern concept that was not relevant to medical device submissions in 1999/2000, particularly for a mechanical implant like an aneurysm clip.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not conducted or described. This device is a passive mechanical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
Based on the information, the 'ground truth' for this device appears to be:
- Material Standards: Conformity to ISO and ASTM standards for the titanium alloy.
- Predicate Device Specifications/Performance: Comparative analysis against the established design specifications and reported performance of the predicate aneurysm clips (Aesculap Titanium Aneurysm Clip, Taka Aneurysm Clip). This would have involved reviewing the predicate device's 510(k) or available technical data.
- Bench Testing: Implicitly, functional testing to confirm the spring-operated, self-closing mechanism, appropriate closure force, and MRI compatibility (e.g., magnetic susceptibility testing).
There is no mention of pathology, outcomes data, or expert consensus in relation to establishing performance criteria for this device.
8. The Sample Size for the Training Set
This information is not applicable and not provided. This device is a mechanical implant; it does not involve an "algorithm" or "AI" that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as #8.
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JAN - 6 2000
SECTION 6 510(k) SUMMARY
Page 14
| Submitter Name: | Pacific Surgical Innovations, Inc. |
|---|---|
| Submitter's Address: | 360 Industrial RoadSan Carlos, CA 94070 |
| Contact Person: | Terry Johnston, President |
| Phone Number: | 650-802-6988 |
| Facsimile Number: | 650-802-0120 |
| Date Prepared: | April 15, 1999 |
| Device Trade Name: | PSI Titanium Aneurysm Clip |
| Device Common Name: | Aneurysm Clip |
| Classification Name: | Aneurysm Clip, 21 CFR 882.5200 |
| Predicate Device: | Aesculap Titanium Aneurysm Clip (K983758)Taka Aneurysm Clip (K972750) |
| Device Description: | Bent titanium wire which provides a spring operated, selfClosing aneurysm clip of various lengths/sizes. |
| Intended Use: | Placement in the intracranial space for the occlusion of acerebral aneurysm (a balloon like sac formed on ablood vessel) to prevent it from bleeding or bursting.Placement of the clip requires the use of especiallydesigned appliers |
| Technological CharacteristicsAnd Comparison to Predicate | The PSI Titanium Aneurysm Clip is manufactured fromthe same materials, to equivalent functional anddimensional specifications as the predicate clips.The material composition is titanium alloy (Ti-6Al-4V).The alloy composition and properties conform with ISOStandard 5832/3: "Implants for Surgery MetallincMaterials - Part 3: WroughtTitanium 6 - Aluminum 4 -Vanadium Alloy" and ASTM Standard F - 136:"Specification for Wrought Titanium 6AL-4V ELI Alloyfor Surgical Applications". The PSI clips share similartolerances, manufacturing controls, packaging andlabeling as the predicate Taka clips. |
| Performance Data: | When used with the appropriate clip applier, as withthe predicate device, the PSI Titanium Aneurysm Clipfunctions in the same manner as the predicate device inthe occlusion of cerebral aneurysms. When used inthe MRI environment, the device presents no additionalrisk to the patient or other personnel, is compatible withcurrent diagnostic imaging equipment and providessubstantially reduced image artifacts over cobalt-basedpredicate clips. |
| Conclusion: | The Titanium Aneurysm Clip is safe and effective for it'sintended use and meets all regulatory requirements to befound substantially equivalent to the predicate device. |
:
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K991959
Page 15
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a stylized symbol. The symbol is a representation of a human figure, with three overlapping profiles suggesting community and support. The seal is presented in black and white.
NOV 2 1 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Pacific Surgical Innovations, Inc. % Mr. Terry Johnston Vice President and General Manager 360 Industrial Road, Unit H San Carlos, California 94070
Re: K991959
Trade/Device Name: Titanium Aneurysm Clip Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm clip Regulatory Class: II Product Code: HCH, HCI Dated: October 28, 1999 Received: November 1, 1999
Dear Mr. Johnston:
This letter corrects our substantially equivalent letter of January 6, 2000.
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 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) that do not require approval of a premarket approval (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 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. Terry Johnston
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally promated notification "ceresults 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), please If you doors operio as no liance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours
FOR Patat Ruma
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 13
SECTION 5
INDICATIONS FOR USE
PSI TITANIUM ANEURYSM CLIP
Device Name:
11:4
Indication for Use:
Permanent placement in the brain for occlusion of cerebral aneurysms. They are only to be applied with PSI clip appliers with titanium alloy jaw inserts
Prescription Use
OR
Over the Counter
to
(Division Sign) Off) Division of General Restor K991959 510(k) Number
§ 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).