(30 days)
The ActivaScrew™ Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.
The ActivaScrew™ Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization. Screws are available as non-cannulated and cannulated, fully and partially threaded, in several different sizes, including diameters of 2.0 – 4.5 mm and lengths of 10 - 90 mm. The ActivaScrew™ Products are made of the completely bioabsorbable poly(L-lactide-coglycolide) (PLGA) material, and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaScrew™ gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place within approximately two years thus eliminating the need for implant removal surgery.
The provided text describes a special 510(k) summary for a modification to the Bioretec ActivaScrew™ and its equivalence to marketed products. It focuses on the device's characteristics and its substantial similarity to predicate devices through in vitro and mechanical bench testing. However, it does not contain any information about acceptance criteria, clinical study design, sample sizes for test or training sets, ground truth establishment, expert qualifications, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request for that specific information based on the provided text. The document primarily addresses regulatory aspects of a device modification and its equivalence based on bench testing, not clinical performance.
Here's what I can extract from the provided text regarding the closest relevant points, acknowledging the missing information:
1. A table of acceptance criteria and the reported device performance
No acceptance criteria or reported device performance for clinical outcomes are mentioned. The document states:
"In vitro and mechanical bench testing determined that the ActivaScrew™ has substantially similar performance as compared to its predicate devices."
This indicates that the "acceptance criteria" were related to achieving "substantially similar performance" in these bench tests, but the specific metrics are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The study mentioned is "in vitro and mechanical bench testing," not a clinical study with human data. Therefore, there's no mention of a test set sample size, data provenance, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as there is no mention of a clinical test set requiring expert ground truth. The "study" was bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or adjudication method is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. A multi-reader multi-case study is not mentioned. The document focuses on bench testing for a bioabsorbable screw.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the device described. The ActivaScrew™ is a physical surgical implant, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "in vitro and mechanical bench testing," the ground truth would be established by engineering standards, physical measurements, and material properties. The document does not specify the exact ground truth used for these tests, only that the performance was "substantially similar" to predicate devices.
8. The sample size for the training set
Not applicable. The described testing is not related to training an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. No AI algorithm training set is mentioned.
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K081392 pge 1 of 2
Image /page/0/Picture/1 description: The image shows the logo for Bioretec. The logo consists of a stylized, curved shape that resembles a wing or a stylized letter 'B'. The shape is filled with a gradient, transitioning from light to dark. Below the shape, the word "bioretec" is written in lowercase letters.
JUN 1 8 2008
ઉ SPECIAL 510(k) SUMMARY
For the modification to Bioretec ActivaScrew™ (K072848)
MANUFACTURER
Bioretec Ltd. Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND
Contact person:
Mrs. Mari Ruotsalainen Quality and Regulatory Affairs Manager Phone: +358 20 778 9514 Fax: +358 3 317 0225 Mari.Ruotsalainen@bioretec.com
Date prepared: May 16th, 2008
DEVICE NAME
Trade Names: Bioretec ActivaScrew™, ActivaScrew™ Cannulated and ActivaScrew™M
Cannulated with ActivaPin™
Common Name: Screw, Fixation, Bone
ESTABLISHMENT REGISTRATION NUMBER
3005536892
DEVICE CLASSIFICATION AND PRODUCT CODE
Device Classification Name: Screw, Fixation, Bone Classification Panel: Orthopedic Regulation Number: 21 CFR 888.3040
Product Code: HWC
PREDICATE DEVICES
Special 510(k): Device Modification, Date: May 16" , 2008
Page G-1
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Image /page/1/Picture/0 description: The image shows the logo for Bioretec. The logo consists of a stylized graphic above the word "bioretec" in lowercase letters. The graphic appears to be an abstract representation of a curved shape, possibly suggesting movement or growth. The overall design is simple and modern.
DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
The ActivaScrew™ Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization. Screws are available as non-cannulated and cannulated, fully and partially threaded, in several different sizes, including diameters of 2.0 – 4.5 mm and lengths of 10 - 90 mm.
The ActivaScrew™ Products are made of the completely bioabsorbable poly(L-lactide-coglycolide) (PLGA) material, and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaScrew™ gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place within approximately two years thus eliminating the need for implant removal surgery.
EQUIVALENCE TO MARKETED PRODUCTS
The ActivaScrew™ bioabsorbable screw is substantially equivalent to biodegradable screws cited as predicate devices above.
The Bioretec ActivaScrew™ has the same intended use, principles of operation and technological characteristic as the previously cleared Bioretec ActivaScrew™ (K072848). The modifications do not raise any questions of safety and effectiveness.
In vitro and mechanical bench testing determined that the ActivaScrew™ has substantially similar performance as compared to its predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2008
Bioretec Ltd. c/o Mrs. Mari Ruotsalainen Quality and Regulatory Affairs Manager Hermiankatu 22, Modulight Building FI-33720 Tampere FINLAND
Re: K081392
Trade/Device Name: ActivaScrew™, ActivaScrew™ Cannulated and
ActivaScrew™ Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: May 16, 2008 Received: May 19, 2008
Dear Mrs. Ruotsalainen:
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.
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Page 2 – Mrs. Mari Ruotsalainen
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 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 vours.
Mark M. Mulhearn
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 0813/2
Image /page/4/Picture/1 description: The image shows the logo for Bioretec. The logo consists of a stylized, curved shape that resembles a wing or a wave, positioned above the word "bioretec" in lowercase letters. The curved shape is darker at the top and fades towards the bottom, creating a sense of movement or flow.
F Indications for Use Statement
| Submitter: | Bioretec Ltd. |
|---|---|
| 510(k) Number: | |
| Device Name: | ActivaScrew TM , ActivaScrew TM Cannulated and ActivaScrew TM Cannulated with ActivaPin TM |
Indications for Use:
The ActivaScrew™ Products are indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.
Contraindications:
-
- Fractures and osteotomies of diaphyseal bone (except those in the hand and foot).
- Situations where internal fixation is otherwise contraindicated, e.g., active or potential 2. infection and where patient's co-operation cannot be guaranteed.
Prescription Use × (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) | |
|---|---|
| -------------------------------------------------------- | -- |
Nei/RPDal forman
Division of General, Restorative, and Neurological Devices
Page of
510(k) Number K081392
Special 510(k): Device Modification, Date: May 16th, 2008
Page F-1
§ 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.