(27 days)
No
The summary describes a material (resin) for reinforcing aneurysms and mentions changes to its formulation and IFU. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
Yes
The device is indicated for "reinforcing and encapsulating of cerebral aneurysms," which directly addresses and treats a medical condition.
No
The device is described as a resin used for reinforcing and encapsulating cerebral aneurysms, which indicates a therapeutic or interventional function, not a diagnostic one.
No
The device description explicitly states it is a self-curing methylmethacrylate (MMA) resin, which is a physical material, 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 reinforcing and encapsulating of cerebral aneurysms." This describes a therapeutic or structural intervention performed in vivo (within the body), not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The device is described as a "self-curing methylmethacrylate (MMA) resin." This is a material used for physical reinforcement and encapsulation, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening
Therefore, based on the provided text, Aneuroplastic® is a medical device used for a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Aneuroplastic® is indicated for the reinforcing and encapsulating of cerebral aneurysms.
Product codes
JXH
Device Description
Aneuroplastic® is a self-curing methylmethacrylate (MMA) resin for reinforcing and encapsulating cerebral aneurysms. The following modifications are being made: A change is being made to the formulation of the liquid component and the Instructions for Use (IFU) is being updated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cerebral aneurysms
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Aneuroplastic® (K873688), SmartSet GMV Endurance Gentamicin Bone Cement (K033382)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5030 Methyl methacrylate for aneurysmorrhaphy.
(a)
Identification. Methyl methacrylate for aneurysmorrhaphy (repair of aneurysms, which are balloonlike sacs formed on blood vessels) is a self-curing acrylic used to encase and reinforce intracranial aneurysms that are not amenable to conservative management, removal, or obliteration by aneurysm clip.(b)
Classification. Class II (performance standards).
0
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| SECTION 4 | 510K SUMMARY |
|---|---|
| ----------- | -------------- |
77
| NAME OF FIRM: | Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham
MA 02767-0350 | JUL 26 2007 |
|-----------------------------------|-------------------------------------------------------------------------------------|-------------|
| 510(k) CONTACT: | Rachel Creane
Senior Regulatory Affairs Specialist | |
| TRADE NAME: | Aneuroplastic® | |
| COMMON NAME: | Methyl Methacrylate (MMA) | |
| CLASSIFICATION: | Class II; 21 CFR 882.5030 | |
| DEVICE PRODUCT CODE: | JXH | |
| SUBSTANTIALLY EQUIVALENT DEVICES: | Aneuroplastic® (K873688)
SmartSet GMV Endurance Gentamicin Bone Cement (K033382) | |
DEVICE DESCRIPTION:
Aneuroplastic® is a self-curing methylmethacrylate (MMA) resin for reinforcing and encapsulating cerebral aneurysms. The following modifications are being made:
A change is being made to the formulation of the liquid component and the Instructions for Use (IFU) is being updated.
INTENDED USE AND INDICATIONS:
Aneuroplastic® is indicated for the reinforcing and encapsulating of cerebral aneurysms.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The substantial equivalence of Aneuroplastic® to the identified predicate devices is demonstrated by its similarity in terms of technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization) to Aneuroplastic® (K873688) and SmartSet GMV Endurance Gentamicin Bone Cement (K033382).
1
Public Health Service
Image /page/1/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2007
Codman & Shurtleff, Inc. % Ms. Rachel Creane Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767-0350
Re: K071776
Trade/Device Name: Aneuroplastic® Regulation Number: 21 CFR 882.5030 Regulation Name: Methyl methacrylate for aneurysmorrhaphy Regulatory Class: II Product Code: JXH Dated: June 28, 2007 Received: July 2, 2007
Dear Ms. Creane:
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 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.
2
Page 2 - Ms. Rachel Creane
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. Milliken
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
K021776
SECTION 5
INDICATIONS STATEMENT
510(k) Number (if known):
Device Name: Aneuroplastic®
Indications for Use:
Aneuroplastic® is indicated for the reinforcing and encapsulating of cerebral aneurysms.
Prescription Use (Part 21 CFR 801.Subpart D)
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)
Mark A. Milliken
(Division Sign-Off) (Division Sign of General, Restorative,
Division of
and Neurological Devices
510(k) Number K071776
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