(30 days)
No
The device description focuses on the material properties and mechanical function of bioabsorbable pins and nails for bone fixation, with no mention of AI or ML.
Yes
The device is indicated for "fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures," which are conditions that require medical therapy.
No
The device is indicated for the fixation of bone fractures, osteotomies, arthrodeses, and osteochondral fractures, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states that the devices are made of bioabsorbable poly(L-lactide-co-glycolide) (PLGA) and are intended for physical fixation of bone fractures, indicating they are physical implants, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization." This describes a surgical implant used directly on the patient's bone.
- Device Description: The description details a bioabsorbable implant made of PLGA that degrades in vivo. This is consistent with a surgical device, not a diagnostic test performed on samples outside the body.
- No mention of in vitro testing: The text does not mention any analysis of samples (blood, urine, tissue, etc.) or any diagnostic purpose.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The devices of Bloretec ActivaPin™ Product Group including ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat and ActivaPin™ HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
Product codes (comma separated list FDA assigned to the subject device)
HTY
Device Description
The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. The modification of the initial ActivaPin™ Product group 510(k) (K080879) adds one trade name; Biorelec ActivaPin™ HT in the AclivaPin™ Product Group. That device has a small modification to ActivaPin™ Fusion; the instrument accepting hole is made on the both ends instead of one end of the device to enable insertions. The labeling will be revised accordingly.
Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices AclivaPin™, ActivaPin™ Fusion, ActivaPin™ HT, ActivaNail™ Conical and ActivaNail™ Flat.
The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin141 HT is the same kind of device as ActivaPin™ Fusion, but it's both ends have an instrument accepting hole. The diameter of ActivaPin™ HT is 1,5 mm and the lengths are 20 - 70 mm.
The devices of Bioretec ActivaPin™ Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osleochondral fractures in the presence of appropriate immobilization.
The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption lakes place within approximately two years thus eliminating the need for implant removal surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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): 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.
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
K133950 (pg 1/3)
JAN 2 2 2014
bioretec
Special 510(k) SUMMARY ਰ
For the modification to Bioretec ActivaPin™ Product Group
MANUFACTURER
Bioretec Ltd. Hermiankatu 22, Modulight Building F1-33720 Tampere FINLAND
Contact person:
Ms. Minna Räsänen Quality and Regulatory Affairs Manager Direct: +358 20 778 9509 Mobile: +358 40 868 1606 Fax: +358 3 317 0225 E-mail: Minna Rasanen@bioretec.com
Date prepared: December 19", 2013
DEVICE NAME
Bioretec ActivaPin™ Trade Name:
Bioretec ActivaPin™ Fusion
Bioretec ActivaNail ™ Conical
Bioretec ActivaNail™ Flat
Bioretec ActivaPin™ HT
Common Name: Pin, Fixation
DEVICE CLASSIFICATION AND PRODUCT CODE
Device Classification Name: Pin, Fixation, Smooth Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Product Code: HTY
PREDICATE DEVICES
Bioretec ActivaPin™ (K061164), Bioretec ActivaPin™ Product Group (K080879)
Special 510(k) Date: December 19th, 2013
G-1 Page
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Image /page/1/Picture/1 description: The image shows the logo for "bioretec". The logo consists of the word "bioretec" in lowercase letters, with a stylized graphic above it. The graphic appears to be three curved shapes, with the shape on the right being solid black and the other two shapes being white with a black outline.
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The modified ActivaPin™ Product Group is identical to the currently cleared device expect for the modification. The modification of the initial ActivaPin™ Product group 510(k) (K080879) adds one trade name; Biorelec ActivaPin™ HT in the AclivaPin™ Product Group. That device has a small modification to ActivaPin™ Fusion; the instrument accepting hole is made on the both ends instead of one end of the device to enable insertions. The labeling will be revised accordingly.
Bioretec ActivaPin™ Product Group covers Bioretec's bioabsorbable devices AclivaPin™, ActivaPin™ Fusion, ActivaPin™ HT, ActivaNail™ Conical and ActivaNail™ Flat.
The Bioretec ActivaPin™ products do not differ significantly or at all in purpose, design, materials, function or any other feature related to safety and effectiveness. ActivaPin™ HT is almost identical with a predicate device and the other devices of Bioretec's ActivaPin™ Product Group. ActivaPin141 HT is the same kind of device as ActivaPin™ Fusion, but it's both ends have an instrument accepting hole. The diameter of ActivaPin™ HT is 1,5 mm and the lengths are 20 - 70 mm.
The devices of Bioretec ActivaPin™ Product Group are indicated for fixation of bone fractures, osteotomies, arthrodeses and osleochondral fractures in the presence of appropriate immobilization.
The Bioretec ActivaPin™ Product Group devices are made of completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA), and they degrade in vivo by hydrolysis into alphahydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the Bioretec ActivaPin™ products gradually loses their strength, however, maintaining their function at least 8 weeks. Bioabsorption lakes place within approximately two years thus eliminating the need for implant removal surgery.
2
K133950 (pg 3/3)
Image /page/2/Picture/1 description: The image shows the logo for bioretec. The logo consists of a stylized, curved shape in black and white, resembling a wing or a wave. Below the graphic is the word "bioretec" in lowercase letters.
EQUIVALENCE TO MARKETED PRODUCTS
The devices of modified Bioretec ActivaPin™ Product Group are substantially equivalent to the previously cleared Bioretec ActivaPin™ (K061164) and Bioretec ActivaPin™ Product Group (K080879).
The modified Bioretec ActivaPin™ products have the same intended use and principles of operation, and also the same technological characteristic and performance as the previously cleared Bioretec ActivaPin™ (K061164) and Bioretec ActivaPin ™ Product Group (K080879). Any differences between modified Bioretec ActivaPin™ products and predicate device do not raise any questions of safety and effectiveness.
Special 510(k) Date: December 19th, 2013
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 22, 2014
Bioretec Limited Ms. Minna Räsänen Quality and Regulatory Affairs Manager Hermiankatu 22, Modulight Building FI-33720 Tampere Finland
Re: K133950
Trade/Device Name: ActivaPin™ Product Group (ActivaPin™, ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat, ActivaPin™ HT) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: December 19, 2013 Received: December 23, 2013
Dear Ms. Räsänen:
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. 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 (reporting of medical
4
Page 2 - Ms. Minna Räsänen
.
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Ronald##Jean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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bioretec
F Indications for Use Statement
| Submitter: | Bioretec Ltd. |
|---|---|
| 510(k) Number: | K133950 |
| Device Name: | ActivaPin™ Product Group |
| ActivaPin™ | |
| ActivaPin™ Fusion | |
| ActivaNail™ Conical | |
| ActivaNail™ Flat | |
| ActivaPin™ HT |
Indications for Use:
The devices of Bloretec ActivaPin™ Product Group including ActivaPin™ Fusion, ActivaNail™ Conical, ActivaNail™ Flat and ActivaPin™ HT are indicated for fixation of bone fractures, osteotomies, arthrodeses and osteochondral fractures in the presence of appropriate immobilization.
Contraindications:
..
-
High-load bearing applications
-
Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient's co-operation cannot be guaranteed.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
.
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page __ of _
Elizabet简必压rank -S
Division of Orthopedic Devices