(59 days)
The Geramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System. are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immabilized following surgery or injury.
The Ceramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury. They are the only invasive components of the Systems. The new Skull Pins include a ceramic tip. The ceramic tip reduces the possibility of an electric current passing to the patient. Such current may cause imaging artifact and/or a burning sensation at the pin insertion points.
This document describes the Ceramic Tipped Skull Pin, a medical device intended for use in Halo Traction Systems. The primary study presented is a laboratory test comparing the Ceramic Tipped Skull Pin to a predicate Titanium Skull Pin based on mechanical integrity.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Ceramic Tipped Skull Pin Performance | Titanium Skull Pin Performance (Predicate) |
|---|---|---|
| Mechanical Integrity (ASTM F 1831-97) | Meets requirements of ASTM F 1831-97, section 11 | Meets requirements of ASTM F 1831-97, section 11 |
| Electrical Safety | Non-conductive | Conductive |
| Imaging Compatibility | Compatible with X-ray, CT, MR | Compatible with X-ray, CT, MR |
| Sterility | EtO Sterilized | EtO Sterilized |
| Materials | Ti6AI4V Titanium, ZrO-ATP BIO-HIP Ceramic, Epoxy | Ti6A14V Titanium |
| Design | Threaded Skull Pin | Threaded Skull Pin |
| Size(s) | 1 size | 2 sizes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of devices. The document mentions "Both the Ceramic Tipped Skull Pins and Generation 80 (Titanium) Skull Pins were tested." This implies at least one of each type, but the exact sample size for the mechanical tests is not detailed.
- Data Provenance: Laboratory tests. The country of origin is not specified, but the manufacturer, Jerome Medical, is based in Moorestown, New Jersey, USA. The data is prospective as it involves new laboratory testing of the devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This study is a laboratory performance test against a recognized standard (ASTM F 1831-97) for mechanical integrity. It does not involve human interpretation or subjective assessment that would require expert ground truth establishment in the traditional sense of clinical or image-based studies. The "ground truth" is defined by the objective pass/fail criteria of the ASTM standard.
4. Adjudication Method for the Test Set
- Not Applicable. As this is a laboratory test against a standard, there is no need for expert adjudication. The test results are objective measurements compared against the standard's requirements.
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
- No. This study is not an MRMC study. It does not involve human readers, AI, or clinical cases to assess diagnostic effectiveness or improvement with AI assistance. It focuses solely on the mechanical performance of a physical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device. There is no algorithm or software involved to have a standalone performance.
7. The Type of Ground Truth Used
- Objective Standard Compliance: The "ground truth" is defined by the requirements of the ASTM F 1831-97 standard, section 11, for mechanical integrity of Halo Rings. The devices were tested to see if they met these predefined, objective criteria.
8. The Sample Size for the Training Set
- Not Applicable. This is a hardware device, not a machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, this question is not relevant.
Summary of the Study:
The study was a laboratory comparison designed to demonstrate the mechanical integrity of the Ceramic Tipped Skull Pin against the predicate Titanium Skull Pin. Both devices were tested in accordance with ASTM F 1831-97, section 11. The key findings were that both the new Ceramic Tipped Skull Pin and the predicate Titanium Skull Pin met the requirements of this standard. The primary differences highlighted for the new device were the use of non-conductive materials for improved image quality and patient safety, and a thicker material for offset load strength, which were confirmed not to adversely affect product performance through these tests.
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APR 1 2 2004
February 3, 2004
510(k) Summary As required by section 807.92(c)
Trade Name: Ceramic Tipped Skull Pins
Common Name: Traction Skull Pins
Classification Name: Single/multiple component metallic bone fixation appliances and accessories Sec. 888.3030 Class II LXT
Substantially Equivalent to: Jerome Traction Skull Pins (included in K822780 and K930153) also manufactured by Jerome Medical. Also similar to Traction Skull Pins included in Bremer Halo System Cervical Traction Skull Pin (K915800, K810193), DePuy Ace Skull Pin and Tong Pin (K974245) Friddle Halo System (K980689), and PMT Halo Systems. Copies of representative product literature are included in Competition (Tab 10).
Description: The Ceramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System, are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immobilized following surgery or injury. They are the only invasive components of the Systems. The new Skull Pins include a ceramic tip. The ceramic tip reduces the possibility of an electric current passing to the patient. Such current may cause imaging artifact and/or a burning sensation at the pin insertion points. Engineering drawings of Ceramic Tipped Skull Pin assemblies are included in Device Name & Description, Tab 2.
| Table 2 | ||
|---|---|---|
| Ceramic Tipped SkullPin | Titanium Skull Pin | |
| Design | Threaded Skull Pin | Threaded Skull Pin |
| Materials | Ti6AI4V Titanium, ZrO-ATP BIO-HIP Ceramic,Epoxy | Ti6A14V Titanium |
| Sterility | EtO Sterilized | EtO Sterilized |
| Sizes | 1 size | 2 sizes |
| Electrical Safety | Non-conductive | Conductive |
| Imaging Compatibility | Compatible w/X-ray, CT,MR | Compatible w/X-ray, CT.MR |
| Performance | Meets requirements ofASTM F 1831 - 97 forMechanical Integrity ofHalo Rings. | Meets requirements ofASTM F 1831 - 97 forMechanical Integrity ofHalo Rings. |
Technological Characteristics Summary:
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040363
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The Ceramic Tipped Skull Pins are substantially equivalent to Skull Pins. Differences are the use of non-conductive materials for improved image quality and patient safety; and thicker material (Halo Skull Pin: 0.3125 inch major diameter Ceramic Tipped Skull Pin vs. 0.250 inch Titanium Skull Pin) for offset load strength. Both clinical and laboratory tests confirm that the new material and design meet the same standard for mechanical integrity as the predicate device.
Laboratory Tests: Both the Ceramic Tipped Skull Pins and Generation 80 (Titanium) Skull Pins were tested to the standard of ASTM F 1831-97, section 11. Both met the standard. A test summary is at page 5-1. The material and design changes do not adversely affect product performance.
Intended Use: The Ceramic Tipped Skull Pins are intended for use in conjunction with the Jerome Halo System that provides cervical immobilization and/or traction for healing and rehabilitation of cervical spinal cord injuries.
Conclusions: The Ceramic Tipped Skull Pins are similar to previously approved Skull Pins in function and indications for use. The devices are substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2004
Mr. Ronald S. Kowalski President Jerome Medical 305 Harper Drive Moorestown, New Jersey 08057
Re: K040363
Trade/Device Name: Ceramic Tipped Skull Pin Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: LYT Dated: February 12, 2004 Received: February 18, 2004
Dear Mr. Kowalski:
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 adultcration.
If your device is classified (sec 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.
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Page 2 – Mr. Ronald S. Kowalski
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark H. Mulkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO40363 510(k) Number (if known):
Device Name: Ceramic Tipped Skull Pin
Indications For Use: The Geramic Tipped Skull Pins are similar to other skull pins which, when used as part of a Halo Traction System. are designed to hold the skull firmly in place relative to the torso so cervical vertebrae are immabilized following surgery or injury.
Prescription Use X (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 CORH, Office of Device Evaluation (ODE)
b. Minh A. Milham
(Division Sign-Off) (Division Sigand Neurological Devices
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510(k) Number K040363
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.