(189 days)
Not Found
No
The summary describes a resorbable bone pin made of PLLA with external features for fixation. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The performance studies section explicitly states that clinical and non-clinical tests are not applicable, which is inconsistent with the typical validation requirements for AI/ML devices.
No
The device is described as a pin for fixation and alignment of bone fragments, fractures, and osteotomies in non-load bearing bones. This is a mechanical support or fixation device, not a device that treats a disease or condition itself.
No
The device is described as being for "fixation and/or alignment of fragments and fractures" and other structural repair, not for identifying or diagnosing a condition.
No
The device description explicitly states the device is composed of physical pins made from poly-L-lactic acid (PLLA), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens 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 BIOTRAK™ Pin is a physical implant used for the fixation and alignment of bone fragments and fractures within the body. It is a surgical device, not a device that analyzes biological samples.
The information provided about the device's material, dimensions, intended use in surgery, and predicate devices all point to it being a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
The BIOTRAK™ Pin is intended for use in fixation and/or alignment of fragments and fractures of non-load bearing bones, osteotomies, arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The ARC Surgical BIOTRAK TM Pin System is composed of pins injection molded from poly-L-lactic acid (PLLA) with diameter 1.5mm to 2.0mm and length 20mm to 40mm. External features on the pin provide increased resistance to loosening of bone fragments. The screws are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
A discussion of clinical and non-clinical tests is not applicable.
Description of the test set, sample size, data source, and annotation protocol
A discussion of clinical and non-clinical tests is not applicable.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A discussion of clinical and non-clinical tests is not applicable.
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.
K041288, K011522, K050259, K991971
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.
Not Found
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
K071616 pg 1 of 2
DEC 1 9 2007
Image /page/0/Picture/1 description: The image shows the logo for ARC Surgical. The logo features the word "ARC" in large, bold letters, with the letter "C" stylized to resemble a target. Below the word "ARC" is the word "SURGICAL" in smaller letters. The target symbol is partially enclosed by a curved line, giving the impression of an arc.
ARC Surgical, LLC 21300 NW Jacobson Rd, Hillsboro, OR 97124
phone: (503) 645-9300 / fax: (503) 645-9304 / web: www.arcsurgical.com
510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter Information: ARC Surgical LLC 21300 NW Jacobson Rd Hillsboro, OR 97124 USA Phone: (503) 645-9300 Fax: (503) 645-9304 Contact: Ed Boehmer, Regulatory Supervisor
| Classification Name: | Bone Fixation Pin |
|---|---|
| Common Name: | Bioabsorbable Bone Fixation Pin |
| Proprietary Name: | ARC Surgical BIOTRAK™ Pin System |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3040 |
| Device Product Code: | HTY |
| Legally Marketed Equivalent Device(s): | Linvatec Biomaterials Ltd. SmartPin (K041288) |
| Biomet, Inc. Resorbable Bone Pins (K011522) | |
| Arthrex, Inc. Bio-Pin (K050259) | |
| Arthrex, Inc. Chondral Dart (K991971) |
Device Description: The ARC Surgical BIOTRAK TM Pin System is composed of pins injection molded from poly-L-lactic acid (PLLA) with diameter 1.5mm to 2.0mm and length 20mm to 40mm. External features on the pin provide increased resistance to loosening of bone fragments. The screws are provided sterile.
Intended Use: The BIOTRAK™ Pin is intended for use in fixation and/or alignment of fragments and fractures of non-load bearing bones, osteotomies, arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities.
These are similar to the intended use of predicate devices and do not raise new issues of safety and effectiveness.
Technological Characteristics: The pins are being injection molded from PLLA pellets (Boehringer-Ingelheim Resomer 210S). The PLLA pellets are polymerized from L-lactide monomers through the process of ring-opening polymerization. Stannous (tin) octoate is utilized as the catalyst. The predicates devices listed use either PLLA, PLA/PGA mix.
A discussion of clinical and non-clinical tests is not applicable.
1
C7til f4→,+2
Image /page/1/Picture/1 description: The image shows the logo for ARC Surgical. The logo consists of the letters "ARC" in a bold, sans-serif font, with the word "SURGICAL" in a smaller font below the letters "AR". The "C" in "ARC" is stylized to resemble a crosshair, with a circle around it.
ARC Surgical, LLC 21300 NW Jacobson Rd, Hillsboro, OR 97124 phone: (503) 645-9300 / fax: (503) 645-9304 / web: www.arcsurgical.com
Based upon the similarities of the ARC Surgical BIOTRAK™ Pin System and the predicate devices studied, the safety and effectiveness of the BIOTRAK.™ Pin is substantially equivalent to the predicate devices referenced.
2
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2007
ARC Surgical, LLC % Mr. Ed Boehmer 21300 NW Jacobson Road Hillsboro, OR 97124
DEC 19 2007
Re: K071616 Trade/Device Name: ARC Surgical BIOTRAK PIN System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: December 5, 2007 Received: December 6, 2007
Dear Mr. Boehmer:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see 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.
3
Page 2 - Mr. Ed Boehmer
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Mulhearn
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications For Use
510(k) Number (if known):
Device Name: ARC Surgical BIOTRAKTM Pin System
Indications For Use:
The BIOTRAK™ Pin is intended for use in fixation and/or alignment of fragments and fractures of non-load bearing bones, osteotomies, arthrodeses, cancellous fragments, and osteochondral fragments in the upper and lower extremities.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ollba Qneyn
(Division Sign Off)
Division of General, Restorative. and Neurological Devices
510(k) Number K07616
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