(443 days)
Not Found
No
The device description focuses on mechanical components, materials, and manual operation, with no mention of AI or ML capabilities.
No.
The device is designed to provide stabilization and rigid fixation of the patient's skull during surgical operations, which is a supportive function during a medical procedure, not a therapeutic intervention itself.
No
Explanation: The device is described as a head rest system for stabilizing and fixing a patient's skull during neurosurgical operations. Its purpose is mechanical support and fixation, not to diagnose a medical condition.
No
The device description details physical components such as clamps, pins, a pistol handle, a pressure indicator, a hydraulic system with a foot pedal, and a base unit, indicating it is a hardware device.
Based on the provided information, the Medicon FIXIT head rest system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide stabilization and rigid fixation of a patient's skull during surgical operations. This is a physical intervention on the patient's body.
- Device Description: The description details a mechanical system for holding the skull in place during surgery. It involves clamps, pins, and a base unit connected to an operating table.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Medicon FIXIT system does not interact with or analyze such specimens.
The device is clearly designed for surgical support and fixation, which falls under the category of surgical instruments or devices used in operative procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Medicon FIXIT head rest system is designed to provide stabilization and rigid fixation of patient's skull during surgical operations. It is indicated for neurosurgical operative procedures.
Product codes
HBL
Device Description
The Medicon Fixit Head Rest System is made from one part, not 2 parts as the competitors systems. The Medicon clamp is designed to prevent closing by accident. The pistol handle with safety lock allows the surgeon a one-hand-use of the clamp. Furthermore, the movable parts are reduced to a minimum. The locking mechanism can be loaded with more than 90 kg.
There is a variety of pin holders available. The choice of pin holders very much depends on the preference of the surgeon, the clinical indication and the type of position of the skull.
The pins are made from Titanium and stainless steel and are delivered nonsterile. The pins are re-usable. At the pistol grip side there is a pressure indicator. By turning the screw the surgeon fixes the skull with a fineadjustment.
Hydraulicus allows via a foot pedal to open and close the connector between the head rest clamp and the operating table which enables the surgeon to manipulate the head rest and / or the patient's head manually and at the same time open and close the locking mechanism with the foot peal.
The base unit is connected to the operating table. As the base unit is equipped with a quick coupling, it may be adapted easily and fast to any operating table.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's skull
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medicon's FIXIT Headrest System is intended for use in healthcare facilities, including hospitals, medical clinics and surgical centers. .
Within these facilities the Medicon Fixit Headrest System may be located in areas such as operating rooms for surgery where sterile instruments are used.
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)
K051440, K001808, K002275, K955012, K912011, K932807
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K083803 Medicon Fixit Headrest
est
Page 1 of 4
MAR 1 0 2010
210(k) SUMMARY OF SAFETY ANRYERMECTIVENESS 2.
Medicon Fixit Headrest System
MAR Ó 5 2010
MEDICON eG
Received
(As required by Section 807.92)
- Submitter (807.92 (a) (1)) 2.1
| MEDICON eG | |
|---|---|
| Gaensaecker 15 | +49 7462 2009 0 |
| Tel. | |
| D-78532 Tuttlingen | Fax: +49 7462 200950 |
| Germany | eMail: sales@medicon.de |
- (807.92 (a) (1)) 2.2 Date Summary Prepared:
November 2009
| 2.3 Device Names | (807.92 (a) (2)) |
|---|---|
| Proprietary: | Medicon Fixit Headrest System |
| Common name: | Neurosurgical Head Holder |
| Device: | Holder, Head, Neurosurgical (Skull Clamp) |
| Classification name: | Neurological Head Holder |
| Classification Code(s) | HBL, 882.4460 |
| Device Class | Class II |
1
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K083803 Medicon Fixit Headrest
est
$$R_{yz} = q_4$$
2.4 Reason for Submission:
((807.81(2))
New Device
Predicate Device (807.92(a)(3)) 2.5
The Medicon FIXIT Headrest System is substantially equivalent to the commercially marketed predicate device and does not raise new issues of safety and effectiveness.
- Schaerer Mayfield Infinity Skull Clamp, Integra Lifesciences Corp. o (K051440)
- Doro Headrest System, PMI Freiburg, Germany (K001808) o
- PS! Skull Clamp, V. Mueller (K002275) o
- Radiolucent Head Frame, Mizuho (K955012) o
- Skull Clamp, Codman (K912011) o
- Mayfield A-2000 Skull Clamp, OHIO Medical (K932807) o
For Predicate Device Catalogs please see Exhibit 4-9.
2.6 Device Description
The Medicon Fixit Head Rest System is made from one part, not 2 parts as the competitors systems. The Medicon clamp is designed to prevent closing by accident. The pistol handle with safety lock allows the surgeon a one-hand-use of the clamp. Furthermore, the movable parts are reduced to a minimum. The locking mechanism can be loaded with more than 90 kg.
There is a variety of pin holders available. The choice of pin holders very much depends on the preference of the surgeon, the clinical indication and the type of position of the skull.
The pins are made from Titanium and stainless steel and are delivered nonsterile. The pins are re-usable. At the pistol grip side there is a pressure indicator. By turning the screw the surgeon fixes the skull with a fineadjustment.
Hydraulicus allows via a foot pedal to open and close the connector between the head rest clamp and the operating table which enables the surgeon to manipulate the head rest and / or the patient's head manually and at the same time open and close the locking mechanism with the foot peal.
The base unit is connected to the operating table. As the base unit is equipped with a quick coupling, it may be adapted easily and fast to any operating table.
2
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Page 3 of 4
- Intended Use (807.92 (a) (5)) 2.7
The Medicon FIXIT head rest system is designed to provide stabilization and rigid fixation of patient's skull during surgical operations. It is indicated for neurosurgical operative procedures.
2.8 Environment of Use
Medicon's FIXIT Headrest System is intended for use in healthcare facilities, including hospitals, medical clinics and surgical centers. .
Within these facilities the Medicon Fixit Headrest System may be located in areas such as operating rooms for surgery where sterile instruments are used.
- Difference in Design and Technological Characteristics when 2.9 compared to SE Devices (807.92 (a) (6))
Material :
Patient contact material for all Headrest Systems consists of titanium or stainless steel. Contact device are the skull pins.
Design:
The design is very similar between the systems. All Headrest Systems consist of skull pins, skull pin holder and Headrest frame. The Medicon design offers also a quick lock, a variety of Skull pin holders and a one part Headrest frame.
2.10 Industry Standards: (807.92 (d))
No applicable industry standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the Medicon's Fixit Headrest System is manufactured in accordance with the MDD 93/42 EEC (please find enclosed the certificate from the notified body), the ISO and the German DIN Standards. Furthermore, the Medicon e. G. has received EN ISO 13485 - 2003 certification.
3
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2.11 Information Bearing on the Safety and Effectiveness: (807.92 (b) (3))
The handling of the Medicon Fixit Headrest System is identical or substantially equivalent to the other commercially available headrest systems. The slight differences in design and size do not adversely affect the safety and effectiveness of this device.
2.12 Comparison with predicate devices (table)
The Medicon`s Fixit Headrest System including tools and accessories claims substantial equivalence to other currently marketed headrest systems. This claim is based on the SE Table and the detailed information provided in the additional document named SE Comparison.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, often interpreted as a symbol of health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Medicon eG % Ms. Tina Volkmer Assistant Research and Development Gaensaecker 15 D-78532 Tuttlingen, Germany
MAR 1 0 2010
Re: K083803
Trade/Device Name: Medicon Fixit Headrest Clamp System Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical head holder (skull clamp) Regulatory Class: Class II Product Code: HBL Dated: February 18, 2010 Received: March 05, 2010
Dear Ms. Volkmer:
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 note: 'CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
5
Page 2 - Ms. Tina Volkmer
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.
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/CDRHOffices/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 (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
83803 Medicon Fixit Headrest
APPENDIX 1
JAN 2 0 2010
Indications for Use
Received
K083803 510(k) Number
Device Name Medicon Fixit Headrest Clamp System
The Medicon FIXIT head rest system is designed to provide stabilization and rigid fixation of patient's skull during surgical operations. It is indicated for neurosurgical operative procedures.
Prescription Use_ × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sien Ciff) Division of Sorgical, Orthopedic, and Restorative Devices
510(k) Number
1