(29 days)
No
The provided text describes a physical implant made of a polymer, its dimensions, packaging, and intended use for bone fixation. There is no mention of software, algorithms, data processing, or any terms related to AI or ML. The name "SmartNail" appears to be a brand name and not indicative of intelligent functionality.
Yes
The SmartNail is intended for use in the "fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses," which are medical procedures aimed at treating or alleviating a disease or injury.
No.
The SmartNail is an implant intended for surgical fixation of bone fragments, not for diagnosing medical conditions.
No
The device description clearly describes a physical implant made of poly-96L/4D-lactide copolymer, with specific dimensions and packaging. It also mentions modifications to instrumentation and an optional silicone cover, all of which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the fixation of bone fragments during surgical procedures (fractures, osteotomies, arthrodeses). This is a therapeutic and structural function within the body.
- Device Description: The device description details the physical characteristics of an implantable medical device (material, size, packaging).
- 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) 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) to provide structural support.
N/A
Intended Use / Indications for Use
Properly used, in the presence of adequate immobilization, 2.4 SmartNail 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.
2.4 SmartNail 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 hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, c.g.,patient conditions, including blood supply limitations, insufficient quantity or quality of bone; active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because 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 2.4mm SmartNail implant is as follows.
- The implant is composed of poly-96L/4D-lactide copolymer. This is the very same implant raw material with SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000, K013546)
- Lengths of implant are 16, 25, 35 and 45 mm. The current product selection of SmartNail products contains 16, 20 and 25 mm long implants. The current product selection of 1.5mm Bone Fixation Kit contains 14, 16, 18, 20 and 25mm long implants
- Diameter of implant is 2.4 mm.
- Shelf life is same with SmartNail™ and 1.5mm Bone Fixation Kit (K012000, -K013546), 3 years.
- Our current packaging style of SmartNail is that aluminium pouch is inner and tyvek®-pouch is outer pouch, implant is placed into cardboard holder. This packaging method is identical for 1.5mm and 2.4 SmartNail implants.
The only modifications that were made are:
- Amendment of one new sizes, 2.4mm in diameter and lengths of 16, 25, 35 and 45 mm
- Revision of design accordingly in longer lengths, more rows of barbs than in shorter nails
- Reference numbers for new sizes. These changes are updated in labelling. -
- Revision of instrumentation accordingly
- Amendment of optional silicone cover for improvement of arthroscopic surgical technique
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Non-load bearing bones, osteotomies and arthrodeses
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
§ 888.3030 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
JUL 2 5 2003
K 0 31 981
510(k) Summary Linvatec Biomaterials 2.4 SmartNail
Submitter's Name, Address, Telephone Number, and Contact Person
Linvatec Biomaterials Ltd. Tuija Annala Director, Quality and Regulatory Affairs P.O.Box 3 FIN-33721 Tampere Finland, Europe Phone: 358-3-316 5600 358-3-316 5629 Facsimile:
Date prepared: June 19, 2003
Name of the device:
- 2.4 Smart Nail A. Trade or Proprietary Name:
- Common Name: B.
Absorbable Bone Fixation Nail Bone Fixation Nail MAI and HWC
Device Product Code: D.
Classification Name:
Predicate Device:
C.
-
- Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) SmartNail (K993074)
Intended Use:
Properly used, in the presence of adequate immobilization, 2.4 SmartNail 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.
2.4 SmartNail 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 hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, c.g.,patient conditions, including blood supply limitations, insufficient quantity or quality of bone; active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4)
1
Treatment of physeal fractures in children, because the effect of the implant upon the healing of growth plate has not been tested clinically.
Device Description:
The device description of the 2.4mm SmartNail implant is as follows.
- The implant is composed of poly-96L/4D-lactide copolymer. This is the very same implant raw material with SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000, K013546)
- Lengths of implant are 16, 25, 35 and 45 mm. The current product selection of SmartNail products contains 16, 20 and 25 mm long implants. The current product selection of 1.5mm Bone Fixation Kit contains 14, 16, 18, 20 and 25mm long implants
- Diameter of implant is 2.4 mm. ו
- Shelf life is same with SmartNail™ and 1.5mm Bone Fixation Kit (K012000, -K013546), 3 years.
- Our current packaging style of SmartNail is that aluminium pouch is inner and । tyvek®-pouch is outer pouch, implant is placed into cardboard holder. This packaging method is identical for 1.5mm and 2.4 SmartNail implants.
The only modifications that were made are:
- Amendment of one new sizes, 2.4mm in diameter and lengths of 16, 25, 35 and 45 i mm
- 。 Revision of design accordingly in longer lengths, more rows of barbs than in shorter nails
- Reference numbers for new sizes. These changes are updated in labelling. -
- Revision of instrumentation accordingly a
- Amendment of optional silicone cover for improvement of arthroscopic surgical ー technique
Substantial Equivalence:
Linvatec Biomaterials Ltd (the previous Bionx Implants Inc.) 2.4 SmartNail is substantially equivalent to the cleared Linvatec Biomaterials Ltd (the previous Bionx Implants Inc.) SmartNail (K993074) and 1.5mm Bone Fixation Kit (K012000, K013546). These changes in design do not raise any new concerns of safety and efficacy of the implant. This modification has no effect on pull-out properties of the device.
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" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines extending from its head, representing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 25 2003
Ms. Tuija Annala Director, Quality and Regulatory Affairs Linvatec Biomaterials Ltd. P.O. Box 3 FIN-33721 Tampere Finland
Re: K031981
Trade Name: 2.4 SmartNail Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: MAI, HWC Dated: June 19, 2003 Received: June 26, 2003
Dear Ms. Annala:
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
3
Page 2 - Ms. Tuija Annala
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. 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,
Sincerely yours,
L-Mark n Mellem
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
510(K) Number (if known):
Device Name: 2.4 SmartNail
Indications for Use:
2.4 SmartNail 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.
2.4 SmartNail 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 hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection; patient conditions, including blood supply limitations, insufficient quantity or quality of bone; and where patient cooperation cannot be guaranteed, (e.g., alcoholism) 4) Treatment of physeal fractures in children, because the effect of 2.4 SmartNail 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)
OR Over-The-Counter Use
Mark A. Milkensen
Division Sign-Off) Division of General. Restorative and Neurological Devices
510(k) Number --