Permanent GIMMI Aneurysm Clips (Yasargil) and vessel clips are intended for Permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary permianent occlusion of blood vessel clips are intended for temporary occlusion Gilvilli Aneurysin Olips (Tabargi) and cerebral aneurysms. They are also intended to be applied exclusively with the corresponding Clip Appliers.

Device Description

GIMMI Aneurysm Clips and their Clip Applying Forceps are used for the occlusion of aneurysms. "Mini" and "Standard" Clips can only be applied with the according Applying forceps; these forceps are labelled with "Mini" or "Standard". Clips are available in different sizes and shapes, to have the right size and shape due to the size and shape of the aneurysm.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the GIMMI Aneurysm Clips and Applying Forceps:

Executive Summary:

The provided document (K081640) is an Abbreviated 510(k) submission for the GIMMI Aneurysm Clips and Applying Forceps. This means that the manufacturer is demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) rather than providing extensive de novo performance data. Crucially, the document explicitly states that "performance testing was not warranted" due to the device's equivalence in design and materials to predicate devices and their long use history. Therefore, there is no detailed study described that establishes explicit acceptance criteria beyond regulatory standards and then proves the device meets those criteria through novel testing.

The "acceptance criteria" can be inferred as compliance with relevant industry standards, material specifications, and the demonstration of substantial equivalence to predicate devices in terms of intended use, performance attributes, materials, and basic design.

1. Table of Acceptance Criteria and Reported Device Performance

As performance testing was not warranted, explicit quantitative acceptance criteria for device performance (e.g., clip strength, fatigue, closure force) are not detailed in this submission. The "reported device performance" is primarily based on the demonstrated equivalence to predicate devices and material biocompatibility.

Acceptance Criterion (Inferred from Submission)	Reported Device Performance
Intended Use (Permanent/Temporary occlusion of blood vessels and cerebral aneurysms)	Identical to predicate devices.
Materials (Titanium per ISO 5832-2/3 or Phynox per ISO 5832-7)	Device manufactured from specified materials. Biocompatibility "given by use of these Clips for over 15 years for human applications" for both Titanium and Phynox materials (referring to predicate devices' material history).
Basic Design	"Identical and/or substantially equivalent to SE devices." Slight modifications in design "do not adversely affect the safety and effectiveness."
Performance Attributes	"Identical and/or substantially equivalent to SE devices." No specific quantitative performance data provided; relies on equivalence statement.
Compliance with Industry Standards (ISO/EN/ASTM/AAMI/ANSI)	GIMMI GmbH certifies compliance "with relevant ISO/EN/ASTM/AAMI/ANSI and other device-related standards that apply to the manufacture, packaging, labelling and reprocessing of subject devices including the validation of these processes."
Sterilization (Autoclavable, delivered non-sterile)	Clip and Applying Forceps are autoclaveable and delivered non-sterile, requiring cleaning and sterilization before use per Operating Instructions.
MR Compatibility (1.5 Tesla or less, 3 Gauss/cm or less, SAR 0.03 W/kg)	"Non-clinical testing has demonstrated that the GIMMI Aneurysm Clip system is MR compatible" under the specified conditions. • No temperature rise or movement observed in 10-minute non-clinical testing with EPI sequences in a SIEMENS MAGNETOM MAESTRO CLASS SYMPHONY MR scanner (1.5 Tesla). Image quality may be compromised if the area of interest is close to the implant.
Bacterial Endotoxins	Tests enclosed (Test 063633-10-A and 063633-10-B) – results not visible in provided text, but implied as compliant.
Safety and Effectiveness	"meet the same criteria of Safety and Effectiveness as SE-Devices." "The results of design validation raise no new issues of safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance

Performance Testing: No dedicated test set in the traditional sense for evaluating device performance against new, quantitative acceptance criteria was used. The submission explicitly states, "Based on the equivalence in design and materials to predicate devices and their use since over 15 Years, performance testing was not warranted."
MR Compatibility Test: A "non-clinical testing" was performed.
- Sample Size: Not explicitly stated for the number of clips tested, but it refers to the "GIMMI Aneurysm Clip system."
- Data Provenance: This was a prospective non-clinical test conducted internally (likely by GIMMI GmbH or a contracted lab) using a "SIEMENS MAGNETOM MAESTRO CLASS SYMPHONY MR scanner." Specific country of origin beyond "Germany" (GIMMI's location) for the testing facility is not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as there was no "test set" requiring expert ground truth for evaluating novel performance. The FDA's substantial equivalence determination relies on comparing the device to existing predicate devices.

4. Adjudication Method for the Test Set

This is not applicable as there was no "test set" requiring adjudication of results against a ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study would compare human performance with and without AI assistance, which is irrelevant for this medical device submission, as it is a physical implant, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study was not done. This device is a physical implant, not an algorithm or AI.

7. The Type of Ground Truth Used

For the overall submission, the "ground truth" for demonstrating safety and effectiveness relies on:

Predicate Device History and Regulatory Approval: The long-standing safe and effective use (over 15 years) and prior regulatory approvals of the identified predicate devices made of similar materials (Titanium, Phynox) and having similar intended uses and designs.
Material Standards and Biocompatibility: Compliance with ISO 5832 for materials and historical evidence of biocompatibility.
Non-Clinical Testing for MR Compatibility: For MR safety, the "ground truth" was established by the experimental results of temperature rise and movement measurements in a specified MR scanner.

8. The Sample Size for the Training Set

This is not applicable as this is a physical medical device submission, not a machine learning model. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no "training set" for this device.

Summary

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Visual Features/ Traits

MAY - 6 2009

081640

The type of material is shown on the packaging label. PERMANENT aneurysm clips made of Titanium can be identified by spectral color (red or blue), TEMPORARY aneurysm clips made of Titanium are gold colored.

PERMANENT Aneurysm clips made of Phynox are of natural color. TEMPORAR Y aneurysm clips made of Phynox have gold plated springs and spring shanks.

All Clips and Applying Forceps are delivered non-sterile and they must be cleaned and sterilized before use according Operating Instructions. Clips and Applying forceps are autoclaveable.

The materials used have already been approved in different instruments and implants, containing Titanium and Phynox. The biocompatibility is given by use of these Clips for over 15 years for human applications.

Aneurysm Clips and Applying forceps are produced according to prevailing standards with the technological characteristics of each clip listed on its labelling.

5.8 Intended Use (807.92(a)(5))

Permanent GIMMI Aneurysm Clips (Yasargil) and vessel clips are intended for permanent occlusion of blood vessels and cerebral aneurysms. Likewise, temporary GIMMI Aneurysm Clips (Yasargil) and vessel clips are intended for temporary occlusion of intra cranial blood vessels and cerebral aneurysms. They are also intended to be applied exclusively with the corresponding Clip Appliers.

5.9 Industry Standards / Performance data (807.92 (d))

GIMMI GmbH certifies compliance with relevant ISO/EN/ASTM/AAMIANSI and other device-related standards that apply to the manufacture, packaging, labelling and reprocessing of subject devise including the validation of these processes.

5.10 Non-Clinical Test Results

Based on the equivalence in design and materials to predicate devices and their use since over 15 Years, performance testing was not warranted. The devices will meet the same criteria of Safety and Effectiveness as SE-Devices.

5.11 Bacterial Endotoxins Test

See tests enclosed, Test 063633-10-A and Test 063633-10-B

5.12 Information Bearing on the Safety and Effectiveness (807.92(b)(3))

GIMMI aneurysm clips have the same intended use as predicate devices. They are made of the same material and are produced to the same international and FDA-recognized standards. Slight modifications in design do not adversely affect the safety and effectiveness of these Devices.

In Summary, the

Intended Use
Performance Attributes
Materials and
V Basic Design

are identical and/or substantially equivalent to SE devices.

The results of design validation raise no new issues of safety and effectiveness.

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5.5 Reason for Submission

Abbreviated 510(k).

5.6 Predicate Devices (807.92(a)(3))

Aesculap, Inc
Rebstock - Instrumente GmbH
V. Mueller Neuro/Spine
Cardinal Health
Medicon, E.G.
Kirwan Surgical Products, Inc

Plus a wide range of other manufacturers/distributors

5.7 Device Description (807.87(a)(4) + (6))

K081640

Clips are available in different sizes and shapes, to have the right size and shape due to the size and shape of the aneurysm.

See item list section 12.

CT- & MR- Safety

GIMMI Aneurysm Clip is manufactured from Titanium acc. to ISO 5832-2 and ISO 5832-3 or Phynox implant steel according to ISO 5832-7.

Non- clinical testing has demonstrated that the GIMMI Aneurysm Clip system is MR compatible. It can be scanned safely under the following conditions:

Static magnetic field of 1.5 Tesla or less
Spatial gradient field of 3 Gaus/cm or less
Maximum whole-body-averaged specific absorption rate (SAR) of 0.03 W/kg for 10 minutes of scanning.

In this non-clinical testing with duration of 10 minutes with EPI (endoplanar imaging) sequences, the GIMMI Aneurysm Clips system produced no temperature rise and no movement.

The test was performed in a SIEMENS MAGNETOM MAESTRO CLASS SYMPHONY MR scanner with a field strength of 1.5 Tesla.

MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the GIMMI Aneurysm Clips system. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.

Image /page/1/Picture/23 description: The image shows a triangle with the letters "MR" inside. To the right of the triangle, the text "= MR CONDITIONAL" is displayed. The image appears to be a symbol or label indicating a specific condition or classification related to "MR".

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Abbreviated 510(k)

K081640

5. SUMMARY of Safety and Effectiveness as required by Section 807.92 (c))

5.1 Submitter

GIMMI GmbH Carl-Zeiss-Str. 6 D-78532 Tuttlingen / Germany

Phone: +49-7461-96590.0 Fax: +49-7461-96590.33 E-mail: info@gimmi.de / u.henzler@gimmi.de

5.2 Contact Person

Scanlan International Mr. Kenneth Blake Vice President One Scanlan Plaza Saint Paul, Minnesota 55107

Phone: 651-298-0997 651-298-0018 Fax E-mail BlakeK@SurgicalTechnologies.com

5.3 Date Summary Prepared (807-92(a)(1)) (a))

June 5, 2008

5.4 Devices Names (807.92 (a)(1))

Yasargil Clip / Applying Forceps Proprietary Name:

Common Name: Aneurysm Clip / Clip Applier

Clip, Aneurysm / Applier, Aneurysm Clip Classification Names

Product Code	Regulation #	Class	Classification Name
84 HCH	882.5200	II	Clip, Aneurysm
84 HCI	882.4175	II	Applier, Aneurysm Clip

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.

MAY - 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Public Health Service

Gimmi GmbH % Scanlan International Mr. Ken Blake One Scanlan Plaza Saint Paul, Minnesota 55107

Re: K081640

Trade/Device Name: GIMMI Aneurysm Clips and Applying Forceps Regulation Number: 21 CFR 882.5200 Regulation Name: Aneurysm clip Regulatory Class: II Product Code: HCH Dated: March 26, 2009 Received: March 30, 2009

Dear Mr. Blake:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. Ken Blakc

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Neil R.P. Ogles
Mark N. Mellon for

Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Abbreviated 510(k)

510(k) Number

GIMMI Aneurysm Clips and Applying Forceps Device Name 84 HCI / 84HCH, 882.4175 + 882.5200

Classification

Class II

Indications for Use

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Keane for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K081640

Page 1 of __

Regulation Number and Section

§ 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).