(90 days)
Not Found
No
The device description and intended use describe a physical implant for cranial surgery, with no mention of software, data processing, or AI/ML terms.
No.
The device's intended use is to cover burr holes and refix cranial bone flaps, which are structural and reparative functions rather than directly treating a disease or condition for therapeutic benefit.
No
The Intended Use states the device is for "covering burr holes and in refixation of cranial bone flaps following a craniotomy," which are therapeutic or reconstructive functions, not diagnostic.
No
The device description clearly states it is a "two piece polymer implant," indicating it is a physical hardware device, not software.
Based on the provided information, the INVISx™ Burr Hole Lock is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for covering burr holes and refixation of cranial bone flaps following a craniotomy. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a two-piece polymer implant used to cover burr holes. This is a physical implant placed within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The description of the INVISx™ Burr Hole Lock does not involve any such testing or analysis of biological samples.
Therefore, the INVISx™ Burr Hole Lock is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The INVISx™ Burr Hole Lock is intended for use in covering burr holes and in refixation of cranial bone flaps following a craniotomy.
Product codes
GXR, GXN
Device Description
The INVISx™ Burr Hole Lock consists of a two piece polymer implant used to cover the burr hole(s) created during cranial surgery.
INVISx™ Burr Hole Lock is packaged sterile and is intended for single (one-time) use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial
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)
Reference Device(s)
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
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).
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SAFETY AND EFFECTIVENESS SUMMARY X. Medtronic Neurosurgery INVISx™ Burr Hole Lock
Kol3000
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.87.
Establishment Registration Number: 2021898
DEC 0 5 2001
Medtronic Neurosurgery Address of Manufacturer: 125 Cremona Drive Goleta CA, 93117 (805) 968-1546 ext. 1773 Fax: (805) 968-5038
Contact Person: Janet McAuley
Date: August 28, 2001
Trade or Proprietary Name: Medtronic INVISx™ Burr Hole Lock
Common, Usual or Classification Name: Burr Hole Cover (21 CFR 882.5250)
Predicate Device Identification:
Medtronic INVISx™ Cranial Fixation System (K010361).
Device Description:
The INVISx™ Burr Hole Lock consists of a two piece polymer implant used to cover the burr hole(s) created during cranial surgery.
INVISx™ Burr Hole Lock is packaged sterile and is intended for single (one-time) use only.
Intended Use:
The INVISx™ Burr Hole Lock is intended for use in covering burr holes and in refixation of cranial bone flaps following a craniotomy.
Intended Use of Predicate Device:
The INVISx™ Cranial Fixation System is intended for use in refixation of cranial bone flaps after a craniotomy.
Technological Comparison:
The INVISx™ Burr Hole Lock is equivalent to the Medtronic INVISx™ Cranial Fixation System (K010361). Substantial equivalence is based upon materials, design, performance specifications and intended use.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 5 2001
Janet McAuley Regulatory Specialist Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117
Re: K013000
Trade/Device Name: Medtronic INVISx™ Burr Hole Lock Regulation Number: 21 CFR 888.5250 and 21CFR 888.5330 Regulation Name: Burr hole Cover and Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXR and GXN Dated: August 28, 2001 Received: September 6, 2001
Dear Ms. McAuley:
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. Iisting 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. Janet McAuley
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin mailing of substantial equivalence of your device to a legally premarket notification. The 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 and 11 you desire specific ad 1809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF N F ar 8659. Additionally, for questions on the promotion and advertising of Compliance at (301) 591-1010 of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general mionnation sturers, International 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,
R. Mark N. Mellema
Celia M. Witten, Ph.D., MD Director Division of General, Restorative And Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Device Name:
INVISx™ Burr Hole Lock
510(k) Number (if known
page 1 of 1
The INVISx™ Burr Hole Lock is intended for use in covering burr holes and in refixation of cranial bone flaps following a craniotomy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Over the Counter Use: or Prescription Use: (Per 21 CFR 801.109)
Mark n Millerson
ral, Restorative
510(k) Number K013000