(443 days)
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.
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.
The provided text describes a 510(k) submission for the Medicon Fixit Headrest System, which is a device for neurosurgical head stabilization. This type of submission focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices, rather than comprehensive de novo clinical studies to prove acceptance criteria based on specific performance metrics.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance, study details (sample size, data provenance, expert qualifications, adjudication methods), MRMC studies, standalone performance data, or training set information.
Instead, the submission relies on the following for demonstrating safety and effectiveness:
1. Table of "Acceptance Criteria" (Implied) and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for novel performance metrics akin to a new drug or efficacy study are not defined. Instead, the "acceptance criteria" are implied by the performance and characteristics of the predicate devices. The "reported device performance" focuses on demonstrating similar functionality and safety characteristics.
| Acceptance Criteria (Implied by Predicate Devices) | Reported Medicon Fixit Headrest System Performance |
|---|---|
| Material Composition: Use of biocompatible and robust materials for patient contact. | Patient contact material for all Headrest Systems consists of titanium or stainless steel. Contact device are the skull pins. |
| Design and Functionality: Ability to provide stabilization and rigid fixation of the patient's skull; similar components (pins, holders, frame). | The Medicon Fixit Headrest System provides stabilization and rigid fixation of patient's skull during surgical operations. The design is very similar between the systems, consisting of skull pins, skull pin holder and Headrest frame. The Medicon design offers a quick lock, a variety of Skull pin holders, and a one-part Headrest frame (compared to two-part competitor systems). It prevents accidental closing, has a pistol handle with safety lock for one-hand use, and reduced movable parts. The locking mechanism can be loaded with more than 90 kg. A pressure indicator allows fine adjustment. Hydraulicus allows foot pedal operation for opening/closing connector between headrest clamp and operating table, enabling manual head manipulation and locking mechanism control. The base unit connects to operating tables with a quick coupling. |
| Safety: Does not raise new safety issues; robust locking mechanism. | The Medicon clamp is designed to prevent closing by accident. The pistol handle has a safety lock. The locking mechanism can be loaded with more than 90 kg. The submission asserts that "the Medicon FIXIT Headrest System is substantially equivalent to the commercially marketed predicate device and does not raise new issues of safety and effectiveness." and "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." |
| Effectiveness: Ability to perform the intended use during neurosurgical operations. | "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." This is directly stated as the intended use, implying effectiveness in this role. |
| Compliance with Standards: Adherence to relevant quality management and medical device standards. | The Medicon's Fixit Headrest System is manufactured in accordance with the MDD 93/42 EEC, ISO, and German DIN Standards. Medicon e.G. has received EN ISO 13485 - 2003 certification. |
2. Sample size used for the test set and the data provenance
The document does not describe a test set or any specific study that involved a sample size of patients or data collected from patients. This is a 510(k) summary focused on engineering specifications and comparison to predicate devices, not clinical performance data from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set involving ground truth established by experts is described.
4. Adjudication method for the test set
Not applicable. No test set involving adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a mechanical headrest system, not an AI-assisted diagnostic or therapeutic tool, so MRMC studies involving human readers and AI are irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm, so standalone performance in this context is irrelevant.
7. The type of ground truth used
Not applicable. No ground truth based on pathology, outcomes data, or expert consensus from clinical cases is mentioned or required for this type of submission focused on substantial equivalence of a mechanical device. The "ground truth" for this submission would essentially be the validated performance and safety of the predicate devices.
8. The sample size for the training set
Not applicable. This is a mechanical device, not a machine learning algorithm, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a mechanical device.
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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 0Tel. |
| 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 |
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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.
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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.
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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.
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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
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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
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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
§ 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).