(59 days)
No
The device description and performance studies focus on the mechanical and material properties of skull pins, with no mention of AI or ML.
Yes
The device is designed to immobilize cervical vertebrae following surgery or injury, which directly contributes to the treatment and healing of a medical condition.
No
The device is described as a component of a Halo Traction System designed to immobilize cervical vertebrae; it is a therapeutic/support device, not one that gathers or interprets data for diagnosis.
No
The device description clearly states it is a physical component (skull pins) used in a Halo Traction System, which are invasive components. It describes material and design changes to the physical pins.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a skull pin used as part of a Halo Traction System. Its purpose is to physically hold the skull in place to immobilize cervical vertebrae following surgery or injury. This is a mechanical, in-vivo (within the body) function.
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze samples or perform any kind of diagnostic test on bodily fluids or tissues.
- Anatomical Site: The device is applied directly to the skull and affects the cervical vertebrae, which are internal anatomical structures.
The device is a surgical/orthopedic device used for mechanical support and immobilization, not for in-vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
LYT
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical vertebrae
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K915800, K810193, K974245, K980689
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 Skull | ||
| Pin | 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 of | |
| ASTM F 1831 - 97 for | ||
| Mechanical Integrity of | ||
| Halo Rings. | Meets requirements of | |
| ASTM F 1831 - 97 for | ||
| Mechanical Integrity of | ||
| Halo Rings. |
Technological Characteristics Summary:
Image /page/0/Picture/11 description: The image shows the word "JEROME" in white letters against a black background. There are two black bars, one above and one below the word. The font is bold and sans-serif. The overall effect is simple and eye-catching.
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040363
Page 2 of 2
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
4
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