(29 days)
Not Found
Not Found
No
The summary describes a bioabsorbable suture fixation device and does not mention any AI or ML components or functionalities.
No
A therapeutic device is one that performs a treatment or cures a disease. This device is used for fixation of suture to bone but does not directly treat or cure a disease.
No
Explanation: The "Intended Use / Indications for Use" states that the Dominator™ is "intended for fixation of suture to bone in orthopaedic procedures," which describes a therapeutic or surgical function, not a diagnostic one.
No
The device description clearly states it is a bioabsorbable device manufactured from a composite mixture of PLLA and calcium phosphate, indicating it is a physical implant, not software.
Based on the provided information, the Dominator™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of suture to bone in orthopaedic procedures." This describes a surgical implant used directly on the patient's body during a procedure.
- Device Description: The description details a bioabsorbable device made of PLLA and calcium phosphate, potentially with sutures. This is consistent with a surgical implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on in vitro analysis.
Therefore, the Dominator™ is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dominator™ is intended for fixation of suture to bone in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis.
Product codes (comma separated list FDA assigned to the subject device)
HWC, JDR
Device Description
Dominator™ is a bioabsorbable device manufactured from a composite mixture of poly-L-lactic acid (PLLA) and calcium phosphate. It may be supplied with sutures with or without pre-attached needles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis.
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
Documentation provided demonstrates that the Dominator™ is substantially equivalent to the predicate device and any differences do not raise concerns regarding safety and effectiveness.
Substantial Equivalence
Documentation provided demonstrates that the Dominator™ is substantially equivalent to the legally marketed predicate device and any differences do not raise concerns regarding safety and effectiveness.
Safety and Performance
Documentation provided demonstrates that the Dominator™ is substantially equivalent to the legally marketed predicate device and any differences do not raise concerns regarding safety and effectiveness.
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.
Not Found
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
K.72127 page 1 of 2
510(k) SUMMARY
AUG 3 1 2007
Dominator™
Biocomposites Ltd Applicant Keele Science Park Keele Staffordshire England ST5 SNL
Contact Person Mr Simon Fitzer +44 (0) 1782 338580 Tel: +44 (0) 1782 338599 Fax Email: sf(@biocomposites.com
Classification Name: Common/Usual Name: Trade/Proprietary Name Product Code
Smooth or threaded metallic bone fixation fastener Suture anchor, bone anchor Dominator™ HWC, JDR
Device Description
Dominator™ is a bioabsorbable device manufactured from a composite mixture of poly-L-lactic acid (PLLA) and calcium phosphate. It may be supplied with sutures with or without pre-attached needles.
Intended Use / Indications
Dominator™ has the exact same intended use and indications as the predicate device. Dominator™ is intended for fixation of suture to bone in orthopaedic procedures.
The indications, contraindications, risks and potential adverse events are the same as the predicate device and is thus substantially equivalent.
1
page 12
Summary of Technology
Dominator™ has the same technological characteristics as the legally marketed predicate device and any differences do not raise concerns regarding safety and effectiveness.
Non Clinical Testing
Documentation provided demonstrates that the Dominator™ is substantially equivalent to the predicate device and any differences do not raise concerns regarding safety and effectiveness.
Substantial Equivalence
Documentation provided demonstrates that the Dominator™ is substantially equivalent to the legally marketed predicate device and any differences do not raise concerns regarding safety and effectiveness.
Safety and Performance
Documentation provided demonstrates that the Dominator™ is substantially equivalent to the legally marketed predicate device and any differences do not raise concerns regarding safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 3 1 2007
Biocomposites Ltd % Mr Simon Fitzer Keele Science Park Keele. Staffordshire England દ્વાર રાત
K072127 Re: Trade/Device Name: DominatorTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR Dated: July 25, 2007 Received: August 2, 2007
Dear Mr. Fitzer:
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.
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. Simon Fitzer
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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 toll-free number (800) 638-2041 or (240) 276-3150 or at the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Merkerson
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):
Dominator™
Device Name:
Indications For Use:
Dominator TM is intended for fixation of suture to bone in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis.
Prescription Use > (Part 21 CFR 801 Subpart D)
Over-The-Counter
(Part 21 CFR 8
Over-The-Counter use No (Part 21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Taubare muem
Page 1 of 1
Division of General, Restorative, and Neurological Devices
510(k) Number K072127