(378 days)
65.XXX /T Series, 55XXX Series, FT XXX T Series / FE XXX K Series
Not Found
No
The device description and intended use clearly describe a physical medical device (aneurysm clips and appliers) and there is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies.
Yes
The device is used for the occlusion of intracranial aneurysms, which constitutes a medical treatment.
No
This device is described as an aneurysm clip, intended for the occlusion (blocking) of intracranial aneurysms. It is a therapeutic device used in treatment, not for diagnosing conditions.
No
The device description explicitly states it is a series of "Aneurysm Clips" and "Appliers," which are physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "occlusion of intracranial aneurysms." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description reinforces the use of the clips for occluding aneurysms, again indicating a direct surgical application.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurysms. They are also intended to be applied exclusively with the 45.XXX and 65.XXX Series Appliers.
Product codes (comma separated list FDA assigned to the subject device)
HCH, HCI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Technological safety and effectiveness is established by the fact that these clips do not contain any new technological risks or characteristics when compared to the legally marketed devices offered here as predicates. They are manufactured according to prevailing standards with the technological characteristics of each clip listed on its labeling.
Safety and hazard analysis has determined that the hazard conditions for the 45.XXX and 65.XXX Aneurysm Clips and Appliers range in the low-tomoderate level and for this reason are acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
65.XXX /T Series, REBSTOCK Implant Steel Aneurysm Clips & Titanium Aneurysm Clips., 55XXX Series, PERNECZKY ANEURYSM CLIP., FT XXX T Series / FE XXX K Series, AESCULAP YASARGIL ANEURYSM CLIP, (TITANIUM or PHYNOX).
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Ko60915
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APR 1 7 2007
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
{as required by 21 CFR, section 807.92( c )}
FOR
KIRWAN SERIES of ANEURYSM CLIPS and APPLIERS
MODELS: 45.XXX, SERIES of KIRWAN L-ANEURYSM-CLIPS and APPLIERS, and 65.XXX, SERIES of KIRWAN YASARGIL-TYPE ANEURYSM CLIPS and APPLIERS.
Common name: Aneurysm Clip / Aneurysm Clip Applier.
Classification name: Aneurysm Clip / Aneurysm Clip Applier (§882.5200 & 882.4175, respectively)
Product code: HCH & HCI, respectively.
Devices Class: Class II
The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurvsms. They are also intended to be applied exclusively with the 45.XXX and 65.XXX Series Appliers.
Technological safety and effectiveness is established by the fact that these clips do not contain any new technological risks or characteristics when compared to the legally marketed devices offered here as predicates. They are manufactured according to prevailing standards with the technological characteristics of each clip listed on its labeling.
Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, MA 02050 Phone: (781) 834-9500 Fax: (781) 834-0022 Contact: Kevin P. Prario, Regulatory Affairs Manager Date prepared: 3/24/2006
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K060915
2/2
There are no applicable performance standards listed for these devices under
Section 514 of the Food, drug and Cosmotio Act, Nonotheloco, Kinyon 45, XXX Section 514 of the Food, drug and Cosmetic Act. Nonetheless. Kirwan 45.XXX and 65.XXX series devices have been tested and manufactured in accordance with prevailing standards and quidelines in order to assure safety and efficacy. Kirwan aneurysm clips and appliers have been found to comply with the requirements of the applicable sections within the following standards and quidelines;
- = ISO 9713, Neurosurgical implants Self-closing intracranial aneurysm clips.
- 트 ISO 5832-2, Metallic Materials - Part 2: Unalloyed titanium.
- ISO 5832-3, Metallic Materials Part 3: Wrought titanium 6-aluminium 4-에 vanadium allov for surqical implant applications.
- ISO 5832-7. Metallic Materials Part 2: Forgeable and cold-formed E cobalt-chromium-nickel-molybdenum-iron alloy.
- 내 F 67 - 95, Standard Specification for unalloyed Titanium for Surgical Implant Applications.
- F 1058 97, Standard Specification for, Wrought Cobalt-Chromium-트 Nickel-Molybdenum-Iron Alloys for Surgical Implant Applications.
- F 136 98, Standard Specification for; Wrought Titanium 6Aluminum l 4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
Safety and hazard analysis has determined that the hazard conditions for the 45.XXX and 65.XXX Aneurysm Clips and Appliers range in the low-tomoderate level and for this reason are acceptable.
Therefore, the 45.XXX and 65.XXX Aneurysm Clips and Appliers are substantially equivalent in intended use, technological safety and effectiveness and performance to the following predicates;
- 65.XXX /T Series, REBSTOCK Implant Steel Aneurysm Clips & Titanium 트 Aneurysm Clips.
- 55XXX Series, PERNECZKY ANEURYSM CLIP. 트
- 트 FT XXX T Series / FE XXX K Series, AESCULAP YASARGIL ANEURYSM CLIP, (TITANIUM or PHYNOX).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the department's name around the perimeter. In the center of the seal is the HHS logo, which consists of a stylized caduceus, a symbol often associated with healthcare. The caduceus has three snakes intertwined around a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kirwan Surgical Products, Inc. % Mr. Kevin Prario Regulatory Affairs Manager 180 Enterprise Drive Marshfield. Massachusetts 05050
APR 1 7 2007
Re: K060915
Trade/Device Name: Models: 45.XXX, Series of Kirwan L-Aneurysm-Clips and Appliers, and 65.XXX, Series of Kirwan Yasargil-Type Aneurysm Clips and Appliers
Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm clip Regulatory Class: II Product Code: HCH Dated: January 16, 2007 Received: January 17, 2007
Dear Mr. Prario:
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 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
3
Page 2 - Mr. Kevin Prario
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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance 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 Manufacturers, International 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/industry/support/index.html .
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Koboqut
Indications for Use
510(k) Number (if known): _____________________
Device Name:
Models: 45.XXX, Series of Kirwan L-Aneurysm-Clips and Appliers, and 65.XXX, Series of Kirwan Yasargil-Type Aneurysm Clips and Appliers.
Indications for Use:
The Kirwan 45.XXX and 65.XXX Series of Aneurysm Clips are intended for either temporary or permanent occlusion of intracranial aneurysms. They are also intended to be applied exclusively with the Kirwan 45.XXX and 65.XXX Series Appliers.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | 1060918 |
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