(103 days)
Not Found
No
The description focuses on mechanical head immobilization and mounting, with no mention of AI/ML or related concepts like image processing for analysis or decision-making.
No
The device is described as a head fixation device used to immobilize the patient's head for MRI procedures, not to treat or diagnose a disease. It primarily serves as a mechanical support system.
No
This device is described as a Head Fixation Arc and Table Base, designed to clamp and hold a patient's head for MRI procedures and immobilize it during surgical procedures. Its function is to position and stabilize, not to diagnose a condition.
No
The device description explicitly details physical components like a "Head Fixation Arc and Table Base" designed to "clamp and hold the patients head" and provide a "mounting method for the headcoil and optional camera system." This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Head Fixation Arc and Table Base is a physical device designed to immobilize a patient's head during an MRI procedure. It does not analyze biological samples or provide diagnostic information based on those samples.
- Intended Use: The intended use clearly states it's for "clamping and holding the patients head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets." This is a mechanical support function, not a diagnostic test.
Therefore, this device falls under the category of a medical device used for patient positioning and support during imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Head Fixation Arc and Table Base is intended for use as a device to clamp and hold the patients head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.
Product codes
HBL
Device Description
The Head Fixation Arc and Table Base is designed to immobilize the patients head during the surqical procedure. It has secondary design intent to provide mounting method for the headcoil and optional camera system. The patient's head is positioned inside the headcoil and attached rigidly to the Head Fixation Arc. The patients head never touches the head coil.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
brain structure and targets (patient's head)
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)
Performance Testing - Bench
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
§ 882.4460 Neurosurgical head holder (skull clamp).
(a)
Identification. A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.(b)
Classification. Class II (performance standards).
0
Summary
This summary of a Traditional 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the SurgiVision Head Fixation Arc and Table Base.
- AUG 2 § 2009 1. Company making the submission:
| Name of Owner: | SurgiVision, Inc. |
|---|---|
| Address: | 5 Musick |
| Irvine, CA 92618 | |
| Telephone: | 949-900-6833 |
| Fax: | 949-900-6834 |
| Contact: | Edward Waddell |
| E-mail: | Ewaddell@surgivision.com |
| Correspondent: | J. Harvey Knauss |
| Address: | 11984 South Evelyn Circle |
| Houston, Texas 77071-3404 | |
| Telephone: | 713-723-4080 |
| Fax: | 713-723-0786 |
| E-mail: | harvey.knauss@gmail.com |
2. Device Name:
| Common Name: | Neurological head
holder |
|--------------------|-------------------------------------|
| Proprietary Name: | Head Fixation Arc and
Table Base |
| Regulation Number: | 882.4460 |
| Product Code: | HBL |
Predicate Device: 3.
K071179, Noras OR Head Holder, Siemens Medical Solutions USA, Inc. Malvern PA 19355 and K874298, Malcolm-Rand Micro neurosurgical Cranio-XRay Frame. Engineered Orthopedic Technologies, Inc., San Clemente, CA.
Summary Head holder tracked dor Delphi Consulting Group
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(191439 P. 2 of 3
4. Intended Use Statement:
The Head Fixation Arc and Table Base is intended for use as a device to clamp and hold the patients head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.
5. Description of Device:
The Head Fixation Arc and Table Base is designed to immobilize the patients head during the surqical procedure. It has secondary design intent to provide mounting method for the headcoil and optional camera system. The patient's head is positioned inside the headcoil and attached rigidly to the Head Fixation Arc. The patients head never touches the head coil.
6. Summary of the technological characteristics of the device compared to the predicate device:
The candidate device, this submission, has the same method of construction and use as the predicates.
7. Testing:
Testing to applicable Standards has been completed with positive outcomes.
Top level of testing performed:
Performance Testing - Bench
8. Rx or OTC:
The Head Fixation Arc and Table Base is an Rx prescription device per 21 CFR Subpart D.
Summary Head holder tracked.doc
Delphi Consulting Group
Houston, TX 77071
14
2
9. Conclusions:
KOG 1439 2.3 083
The Head Fixation Arc and Table Base is equivalent to the predicate devices in the scope of practical application, effectiveness at this application, and ensuring the safety of its subject.
The Head Fixation Arc and Table Base do not raise any new safely or effectiveness issues.
SurgiVision, Inc.
Eduard Waldelu
Edward Waddell Director of Regulatory Affairs
Date: July 22, 2009
Head holder tracked.
Section 5 510(k) Submission Page #
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Image /page/3/Picture/0 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the edge. In the center of the seal is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 5 2009
Surgi Vision, Inc. c/o Mr. J. Harvey Knauss Contract Consultant Dephi Consulting Group (DCG) 11874 South Evelyn Circle HOUSTON TX 77071
Re: K091439
Trade/Device Name: Head Fixation Arc and Table Base Regulation Number: 21 CFR §882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: II Product Code: HBL Dated: July 22, 2009 Received: July 28, 2009
Dear Mr. Knauss:
We have reviewed vour 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 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); medical device reporting (reporting of medical
4
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (2.1 CFR Part 803), please go to http://www.fda.gov/cdrl/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K091439
Device Name: Head Fixation Arc and Table Base
The Head Fixation Arc and Table Base is intended for use as a device to clamp and hold the patients head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.
Prescription Use YES (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)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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Section 4 510(k) Submission Page #
Indcations for use form.doc Delphi Consulting Group Houston, TX 77071