(21 days)
No
The device description focuses on the material, dimensions, and packaging of a bone fixation kit, with no mention of AI or ML capabilities. The predicate device is also a bone fixation device without apparent AI/ML features.
Yes.
The device is intended for the fixation of bone fragments, osteotomies, and arthrodeses, which are therapeutic medical procedures.
No
The device, a 1.5mm Bone Fixation Kit, is described as intended for the fixation of fractured bones, osteotomies, and arthrodeses, indicating a therapeutic or surgical purpose rather than a diagnostic one.
No
The device description explicitly states that the device is a "Bone Fixation Kit" and describes physical implants made of poly-L/D-lactide copolymer with specific dimensions. This indicates a hardware medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses." This describes a surgical implant used to physically stabilize bone fragments.
- Device Description: The device description details a "Bone Fixation Kit" with implants made of poly-L/D-lactide copolymer, with specific lengths and diameters. This is consistent with a medical device used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for structural support.
N/A
Intended Use / Indications for Use
Properly used, in the presence of adequate immobilization, 1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.
1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the I ractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment and where pation of operation vecause the effect of the implant upon the healing of growth plate has not been tested clinically.
Product codes
MAI, HWC
Device Description
The device description of the 1.5mm Bone Fixation Kit is as follows.
- The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074)
- Lengths of implants are 16, 18, 20 and 25 mm. -
- Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) 1
- Design of the implant of 1.5mm Bone Fixation Kit is identical with SmartNail -(K993074).
- Shelf life is same with SmartNail™ -
- Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-load bearing bones
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
012000
JUL 1 8 2001
510(k) Summary Bionx Implants Inc. 1.5mm Bone Fixation Kit
Submitter´s Name, Address, Telephone Number, and Contact Person
Bionx Implants, Inc. 1777 Sentry Parkway West Gwynedd Hall, Suite 400 Bluebell, PA 19422
Contacts:
Gerard S. Carlozzi President and CEO (215) 643-5000 Phone: (215) 653-0984 Facsimile:
Bionx Implants Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland, Europe 358-3-316 5600 Phone: 358-3-316 5629 Facsimile:
June 15th, 2001 Date prepared:
Name of the device:
| A: | Trade or Proprietary Name: | 1.5mm Bone Fixation Kit |
|---|---|---|
| B: | Common Name: | Absorbable Bone Fixation Nai |
| C: | Classification Name: | Bone Fixation Nail |
| D: | Device Product Code: | MAI |
Predicate Device:
- Bionx Implants, Inc. SmartNail (K993074)
Intended Use:
Properly used, in the presence of adequate immobilization, 1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.
1
1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the I ractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment and where pation of operation vecause the effect of the implant upon the healing of growth plate has not been tested clinically.
Device Description:
The device description of the 1.5mm Bone Fixation Kit is as follows.
- The implants are composed of poly-L/D-lactide copolymer. This is the very same raw material with SmartNail (K993074)
- Lengths of implants are 16, 18, 20 and 25 mm. -
- Diameter of implants is 1.5mm. This is identical with SmartNail (K993074) 1
- Design of the implant of 1.5mm Bone Fixation Kit is identical with SmartNail -(K993074).
- Shelf life is same with SmartNail™ -
- Implants and single use, sterile, disposable instruments are packed into blister, which is sealed with the Tyvek® lid. Blister with Tyvek® lid is packed into aluminium foil pouch and sealed.
Substantial Equivalence:
Bionx Implants Inc. 1.5mm Bone Fixation Kit is substantially equivalent to the cleared Bionx Implants Inc. SmartNail (K993074) have the same intended use and principles of operation and very similar technological characteristics.
The instrument set is substantial equivalent with previously cleared Bionx Implants Inc. SmartNail (K993074). Furthermore, the minor technological differences between the Bionx Implants Inc. 1.5mm Bone Fixation Kit and the predicate devices do not raise any new issues of safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with outstretched arms, possibly representing care or support.
ັງບໍ່ 1 8 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tuija Annala Director, Quality and Regulatory Affairs Bionx Implants, Ltd. P.O. Box 3 FIN-33721 Tampere Finland
Re: K012000
Trade Name: 1.5mm Bone Fixation Kit Regulation Number: 888.3030 Regulatory Class: II Product Codes: HWC and MAI Dated: June 15, 2001 Received: June 27, 2001
Dear Ms. Annala:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becally b really is substantially equivalent (for the indications for use above and we nave determinou the actected predicate devices marketed in interstate commerce stated in unc encrosure) to logally manufacted of the Medical Device Amendments, or to devices that provision in accordance with the provisions of the Federal Food, Drug, and nave bech lectassified in accordance wre, market the device, subject to the general controls Costicity of the Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general vonanufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 centuries) in the Code of Federal Regulations, Title 21, Parts 800 to 895. arresting Jour as 1999 views determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mispections, the Food and Drage may result in regulatory action. In addition, FDA may publish comply with the Orize registerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Tuija Annala
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonication. The I Dri Imanig of sussion 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 and If you desire specific active rest diagnostic devices), please contact the Office of Compliance at additionally 607.10 for mirritie and ussions on the promotion and advertising of your device, (301) 591 1057. Tradition for at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers 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,
NSMut chleeting fo
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Devices Evaluation Center for Devices and Radiological Devices
Enclosure
4
INDICATIONS FOR USE
01 2000
510(K) Number (if known):
Device Name:
1.5mm Bone Fixation Kit
Indications for Use:
1.5mm Bone Fixation Kit is intended for use in the fixation of fragments of fractured 1.3mm Done I ration interness and arthrodeses, for example in the fixation of non-load fragments, osteochondral fragments and cancellous/non-load bearing fragments.
1.5mm Bone Fixation Kit is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the I ractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment and where patient be operation, because the effect of 1.5mm Bone Fixation Kit upon the healing of growth plate has not been tested clinically.
(Please do not write below this line - continue on another page is needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use_ OR
BSmutheloora A canu
Division Sign Division of General, Restorative and Neurological Devices
510(k) Number KO12000