(97 days)
No
The device description and performance studies focus on mechanical properties and biocompatibility, with no mention of AI or ML.
Yes
The device is used to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions, which are therapeutic actions.
No
This device is used for immobilization and traction of the cervical spine, which are therapeutic actions, not diagnostic ones. It provides rigid support for procedures like diagnostic examinations, but it does not perform the diagnosis itself.
No
The device description explicitly details hardware components such as titanium threaded skull pins, aluminum crown/ring, aluminum rod superstructure, and a lined polymer vest. The performance studies also focus on testing these physical components.
Based on the provided information, the Anjon Bremer Halo System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions. This is a direct therapeutic intervention on the patient's body.
- Device Description: The device consists of physical components (skull pins, crown, ring, superstructure, vest) that are applied externally and internally (skull pins) to the patient's body for structural support and immobilization.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Performance Studies: The performance studies described focus on the mechanical strength, biocompatibility, and sterility of the device components, which are typical for a physical medical device, not an IVD.
Therefore, the Anjon Bremer Halo System is a physical medical device used for immobilization and traction, not an IVD.
N/A
Intended Use / Indications for Use
The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.
Product codes (comma separated list FDA assigned to the subject device)
JEC
Device Description
The Anion Bremer Halo System consists of transcutaneous bone anchorage elements. and extracutaneous bridge elements, which provide fixation of the skull relative to the torso to immobilize the cervical spine when used with a frame or surgical table adaptor.
The transcutaneous bone anchorage elements are titanium threaded skull pins. of which four (4) skull pins attach to an aluminum crown or ring positioned below the head equator. The crown or ring is then attached to an aluminum rod superstructure, which is attached to a lined polymer vest, or attached to a surgical table using the Mayfield adaptor.
Fixation of the selected bridge element (crown or ring) to the patient skull is accomplished using tight connection of the titanium threaded skull pins up to a maximum specified torque. The head is then held in extension when the frame (vest and superstructure) are connected to the bridge element, at which time reduction occurs. For rigid support during diagnostic examination or surgical procedure, the bridge element can be connected to the surgical table through use of the Mayfield adaptor. Cervical spine immobilization and therapeutic traction occurs as localized rotation and flexion motion is eliminated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, skull
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)
Non-clinical testing of the Anjon Bremer Halo System in support of this submission included the following activities:
- Testing of the Skull Pins to failure under load (ASTM F1541).
- Biocompatibility assessment of the manufactured Skull Pins which included elutionbased Cytotoxicity, Sensitization, Intracutaneous Reactivity and Material Mediated Pyrogenicity testing (ISO 10993).
- Testing of the Halo for deformation under load at maximal load and sustained half load conditions (ASTM F1831).
- Testing of the product and sterile barrier per ISO 11607-2:
- Product stability after high dose gamma irradiation and accelerated aging after simulated one- and three-year aging. This included repeating at each time point:
- Testing of the Skull Pins to failure under load (ASTM F1541).
- Testing of the Halo for deformation under load at maximal load and sustained half load conditions (ASTM F1831).
- Sterile barrier stability and integrity tests after simulated transportation stress.
- Sterile barrier stability and integrity tests after high dose gamma irradiation and accelerated aging at simulated one- and three-year aging.
The above testing was done in addition to the studies required to validate the sterility of the product using the VDmax25 method (ISO 11137).
- Product stability after high dose gamma irradiation and accelerated aging after simulated one- and three-year aging. This included repeating at each time point:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
March 2, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Anjon Holdings LLC Kenneth Collins General Manager 4801 Dawin Road JACKSONVILLE, FL 32207
Re: K193256
Trade/Device Name: Anjon Bremer Halo System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: JEC Dated: February 7, 2020 Received: February 10, 2020
Dear Kenneth Collins:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ting Song, Ph.D Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Anjon Bremer Halo System
Indications for Use (Describe)
The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition
| Type of Use (Select one or both, as applicable) | |
|---|---|
| [X] Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Anjon Holdings. The word "Anjon" is in a serif font, with the "A" in blue and the rest of the letters in black. Below the word "Anjon" is the word "Holdings" in a smaller, sans-serif font, also in blue. The logo is simple and professional, and the use of blue and black gives it a clean and modern look.
510(k) Summary
Applicant
Anjon Holdings, LLC 4801 Dawin Rd Jacksonville, FL 32207
Official Correspondent/Contact Person
Kenneth A Collins General Manager Anjon Holdings LLC
Tel: (904) 730-9373 Email: kcollins@anjonholdings.com
Date Prepared: 25 February , 2019
Device Name
| Trade name: | Anjon Bremer Halo System |
|---|---|
| Common/Usual Name: | Cervical external halo fixture |
| Classification Name: | Component, traction, invasive |
| Regulation Number: | 888.3040 |
| Product Code: | JEC |
| Classification: | II |
| Panel: | Orthopedic |
Predicate Devices
The Anjon Bremer Halo System acts as its own predicate. In addition is substantially equivalent to the Bremer Halo System Cervical Traction Skull Pin produced by Bremer Medical, Inc and the Bremer Halo System Titanium Skull Pin produced by DePuy Acromed, marketed as Bremer Halo System. The Bremer Halo System Cervical Traction Skull Pin is the Primary Predicate and the Bremer Halo System Titanium Skull Pin is a Reference Predicate, as shown below with corresponding 510(k) numbers.
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Image /page/4/Picture/1 description: The image shows the logo for Anjon Holdings. The word "Anjon" is written in a serif font, with the "A" in blue and the rest of the letters in black. A horizontal line is below the word "Anjon", and the word "Holdings" is written in a smaller, blue, sans-serif font below the line.
Table 2 Predicate devices
| 510(k) Number | Device | Manufacturer |
|---|---|---|
| K171863 | Anjon Bremer Halo System | Anjon LLC |
| K915800 | Bremer Halo System Cervical Traction Skull | Bremer Medical, Inc |
| K993099 | Bremer Halo System Titanium Skull Pin | De Puy Acromed |
Description of the Device
The Anion Bremer Halo System consists of transcutaneous bone anchorage elements. and extracutaneous bridge elements, which provide fixation of the skull relative to the torso to immobilize the cervical spine when used with a frame or surgical table adaptor.
The transcutaneous bone anchorage elements are titanium threaded skull pins. of which four (4) skull pins attach to an aluminum crown or ring positioned below the head equator. The crown or ring is then attached to an aluminum rod superstructure, which is attached to a lined polymer vest, or attached to a surgical table using the Mayfield adaptor.
Fixation of the selected bridge element (crown or ring) to the patient skull is accomplished using tight connection of the titanium threaded skull pins up to a maximum specified torque. The head is then held in extension when the frame (vest and superstructure) are connected to the bridge element, at which time reduction occurs. For rigid support during diagnostic examination or surgical procedure, the bridge element can be connected to the surgical table through use of the Mayfield adaptor. Cervical spine immobilization and therapeutic traction occurs as localized rotation and flexion motion is eliminated.
Indications for Use
The Anjon Bremer Halo System is indicated for use to provide cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck condition.
Summary of Technological Characteristic Comparison
The technological characteristics of the Anjon Bremer Halo System are equivalent to the predicate devices, as outlined in Table 3 below.
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Image /page/5/Picture/1 description: The image shows the logo for Anjon Holdings. The word "Anjon" is in a bold, serif font, with the "A" in blue and the rest of the letters in black. Below the word "Anjon" is the word "Holdings" in a smaller, sans-serif font, with a line on either side of the word.
Anjon Holdings LLC 4801 Dawin Road, Jacksonville FL 32207, USA 傘+1.904.730.9373
| Applicant | Anjon LLC | Anjon LLC | Bremer Medical, Inc | De Puy Acromed |
|---|---|---|---|---|
| SUBJECT | ||||
| DEVICE | Primary Predicate | PREDICATE | PREDICATE | |
| Product Name | Anjon Bremer | |||
| Halo System | Anjon Bremer Halo | |||
| System | Bremer Halo System | |||
| Cervical Traction Skull | ||||
| Pin | Bremer Halo System | |||
| Titanium Skull Pin | ||||
| 510(k) Number | TBD | K171863 | K915800 | K993099 |
| Product Code | JEC | JEC | JEC | JEC, HWC |
| Regulation # | 21CFR 888.3040 | 21CFR 888.3040 | 21CFR 888.3040 | 21CFR 888.3040 |
| Class | II | II | II | II |
| Prescription or O-T-C? | Prescription | Prescription | Prescription | Prescription |
| Provided Sterile or | ||||
| Non-sterile? | Sterile | Non-sterile | Sterile | Sterile |
| Indications for Use | Intended for | |||
| use to provide | ||||
| cervical spine | ||||
| immobilization | ||||
| and therapeutic | ||||
| traction for | ||||
| treatment of | ||||
| patients with | ||||
| cervical trauma | ||||
| or other neck | ||||
| condition | Intended for use to | |||
| provide cervical spine | ||||
| immobilization and | ||||
| therapeutic traction for | ||||
| treatment of patients | ||||
| with cervical trauma or | ||||
| other neck condition | Intended for use to | |||
| provide cervical spine | ||||
| immobilization and | ||||
| therapeutic traction | ||||
| for treatment of | ||||
| patients with cervical | ||||
| trauma or other neck | ||||
| condition | Intended for use in | |||
| conjunction with | ||||
| Bremer's Halo | ||||
| System cervical | ||||
| traction devices and | ||||
| accessories, which | ||||
| provide cervical | ||||
| immobilization for | ||||
| treatment of patients | ||||
| for healing and | ||||
| rehabilitation of | ||||
| cervical spinal cord | ||||
| injuries | ||||
| Components | Crown (Metal or | |||
| Nylon 66/Glass | ||||
| 50%) | Crown (Metal) | |||
| Adjustable Ring (Metal) | ||||
| Positioning Pins (Polymer) | Halo Crown (Metal) | |||
| Adjustable Halo Ring | ||||
| (Metal) | ||||
| Positioning Pins (Polymer) | Nylon 66/Glass 50% | |||
| chopped strand co- | ||||
| extrusion. | ||||
| Applicant | Anjon LLC | Anjon LLC | Bremer Medical, Inc | De Puy Acromed |
| SUBJECT | ||||
| DEVICE | Primary Predicate | PREDICATE | PREDICATE | |
| Product Name | Anjon Bremer | |||
| Halo System | Anjon Bremer Halo | |||
| System | Bremer Halo System | |||
| Cervical Traction Skull | ||||
| Pin | Bremer Halo System | |||
| Titanium Skull Pin | ||||
| Adjustable Ring | ||||
| (Metal) | ||||
| Positioning Pins | ||||
| (Polymer) | ||||
| Positioning Pads | ||||
| (Polymer) | ||||
| Plastic molded vest | ||||
| (Polymer) | ||||
| Vest liner | ||||
| (synthetic | ||||
| lambskin) | ||||
| Rod superstructure | ||||
| (metal) with halo | ||||
| clamps (polymer) | ||||
| Threaded screw | ||||
| skull pin (Alloy) – | ||||
| spi9ke or drill tip. | ||||
| Torque Limiter | ||||
| (Titanium) | Positioning Pads | |||
| (Polymer) | ||||
| Plastic molded vest | ||||
| (Polymer) | ||||
| Vest liner (synthetic | ||||
| lambskin) | ||||
| Rod superstructure | ||||
| (metal) with halo clamps | ||||
| (polymer) | ||||
| Threaded screw skull pin | ||||
| (Alloy) | ||||
| Torque Limiter (Polymer) | Positioning Pads | |||
| (Polymer) | ||||
| Plastic molded vest | ||||
| (Polymer) | ||||
| Vest liner (synthetic | ||||
| lambskin) | ||||
| Rod superstructure | ||||
| (metal) with halo clamps | ||||
| (polymer) | ||||
| Threaded screw skull pin | ||||
| (Alloy) | ||||
| Torque Limiter (Polymer) | Threaded screw skull pin | |||
| (Alloy) - drill tip | ||||
| Accessories | Torque wrench | |||
| Head spoon | ||||
| ICU Fast Release | ||||
| Bolts | ||||
| Mayfield Adapter | ||||
| Set | Torque wrench | |||
| Head spoon | ||||
| ICU Fast Release Bolts | ||||
| Mayfield Adapter Set | Torque wrench | |||
| Head spoon | ||||
| ICU Fast Release Bolts | ||||
| Mayfield Adapter Set | Not applicable |
Table 3 Comparison to Predicate
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Image /page/6/Picture/1 description: The image shows the logo for Anjon Holdings. The word "Anjon" is written in a serif font, with the "A" in blue and the rest of the letters in black. Below the word "Anjon" is the word "Holdings" in a smaller, blue serif font, with a horizontal line on either side.
Anjon Holdings LLC
4801 Dawin Road, Jacksonville FL 32207, USA
傘+1.904.730.9373
7
Image /page/7/Picture/1 description: The image shows the logo for Anjon Holdings. The word "Anjon" is written in a serif font, with the "A" in blue and the rest of the letters in black. Above the "i" is a black dot. Below the word "Anjon" is the word "Holdings" in a smaller, blue serif font, with a blue line on either side of the word.
Anjon Holdings LLC 4801 Dawin Road, Jacksonville FL 32207, USA 傘+1.904.730.9373
| Applicant | Anjon LLC | Anjon LLC | Bremer Medical, Inc | De Puy Acromed |
|---|---|---|---|---|
| SUBJECT | ||||
| DEVICE | Primary Predicate | PREDICATE | PREDICATE | |
| Product Name | Anjon Bremer | |||
| Halo System | Anjon Bremer Halo | |||
| System | Bremer Halo System | |||
| Cervical Traction Skull | ||||
| Pin | Bremer Halo System | |||
| Titanium Skull Pin | ||||
| Sterilization Methodology | Co60 Gamma | |||
| Irradiation | Not applicable | Ethylene Oxide | Ethylene Oxide |
8
Image /page/8/Picture/1 description: The image shows the logo for Anjon Holdings. The word "Anjon" is written in a serif font, with the "A" in blue and the rest of the letters in black. Above the "i" is a black dot. Below the word "Anjon" is the word "Holdings" in a smaller, light blue serif font, with a line on either side.
Description of Non-Clinical Testing
Non-clinical testing of the Anjon Bremer Halo System in support of this submission included the following activities:
- Testing of the Skull Pins to failure under load (ASTM F1541).
- . Biocompatibility assessment of the manufactured Skull Pins which included elutionbased Cytotoxicity, Sensitization, Intracutaneous Reactivity and Material Mediated Pyrogenicity testing (ISO 10993).
- Testing of the Halo for deformation under load at maximal load and sustained half ● load conditions (ASTM F1831).
- . Testing of the product and sterile barrier per ISO 11607-2:
- o Product stability after high dose gamma irradiation and accelerated aging after simulated one- and three-year aging. This included repeating at each time point:
- Testing of the Skull Pins to failure under load (ASTM F1541). .
- . Testing of the Halo for deformation under load at maximal load and sustained half load conditions (ASTM F1831).
- Sterile barrier stability and integrity tests after simulated transportation stress. o
- Sterile barrier stability and integrity tests after high dose gamma irradiation o and accelerated aging at simulated one- and three-year aging.
- o Product stability after high dose gamma irradiation and accelerated aging after simulated one- and three-year aging. This included repeating at each time point:
The above testing was done in addition to the studies required to validate the sterility of the product using the VDmax25 method (ISO 11137).
Conclusion
As documented in this submission, the gamma sterilized Anjon Bremer Halo System is substantially equivalent to its own Anjon Holdings' predicate cleared per K171863. In addition, as a product range extension:
- . The polymer Molded Crown variant of the Halo Crown is substantially equivalent to the anodized aluminium variant cleared per K171863.
- The drill tip Traction Skull Pin (PIN010) is substantially equivalent to the skull ● pins initially cleared under K171863. the Bremer Halo System Cervical Traction Skull Pin predicate device (Primary Predicate - K915800) and Bremer Halo System Titanium Skull Pin (Reference predicate - K993099).
The devices are available by prescription only, and are for single use only. The devices utilize 356-T-6 aluminum, Wrought Titanium-6Aluminum-4VanadiumELI, Aluminum 6061-T6, Nylon 66 resin containing 50% Long Glass, and Resinol type A(LDPE).
It can be concluded that the Anjon Bremer Halo System is substantially equivalent to the predicate devices.