(91 days)
Not Found
No
The summary describes a mechanical bone fixation system and does not mention any AI or ML components.
Yes.
The device is indicated for fixation and stabilization of bone fractures, which is a therapeutic intervention aimed at promoting healing and restoring function.
No
This device is described as an osteosynthesis plate system intended for fixation and stabilization of fractures and other bone procedures, making it a treatment device, not a diagnostic one.
No
The device description clearly states it is a system of physical bone fixation devices (plates and screws) made of Titanium, intended for permanent implantation. This is hardware, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the fixation and stabilization of bone fractures and related procedures. This is a surgical intervention on the body, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The device is a permanently implanted bone fixation system. IVDs are typically used to analyze biological samples (blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
The device described is a surgical implant used for orthopedic procedures.
N/A
Intended Use / Indications for Use
Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
Airlock® osteosynthesis plate systems are single-use bone fixation devices intended to be permanently implanted. Plates are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 3mm or 3,5mm locking and non-locking screws.
The drill hole are aligned to make sure there is no risk of conflict between the screws.
The plates vary essentially through different curvatures, lengths, number of holes and shape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small bones of the hand, feet, wrist, ankles, fingers and toes
Indicated Patient Age Range
adult and pediatric patients
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)
The biocompatibility evaluation for new devices Airlock® osteosynthesis plate systems was conducted in accordance with Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA.
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
§ 888.3030 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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2015
NOVASTEP Mr. Gilles Audic, QA/RA Director Espace performance Alphasis Batiment C1-C2 35769 SAINT GREGOIRE France
Re: K151277
Trade/Device Name: Airlock® osteosynthesis plate system Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: May 21, 2015 Received: May 26, 2015
Dear Mr. Audic:
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
1
Page 2 - Mr. Gilles Audic
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section
4: Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 | |
|---|---|---|
| Indications for Use | Expiration Date: January 31, 2017 | |
| See PRA Statement below. | ||
| 510(k) Number (if known) | K151277 | |
| Device Name | Airlock® osteosynthesis plate systems | |
| Indications for Use (Describe) | Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients. | |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/2 description: The image shows the logo for "novastep". The logo is in a pink color. To the left of the word "novastep" is a pink design that looks like two curved lines. To the right of the word "novastep" is a registered trademark symbol.
"510(k) Summary" as required by section 807.92(c)
| Submitter | NOVASTEP
Espace performance Alphasis
Batiment C1-C2
35769 SAINT GREGOIRE
France
Phone : + 33 (0)2 99 33 86 50
Fax : + 33 (0)9 70 29 18 95 |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person | Mister Gilles AUDIC
QA / RA Director
Cell phone: +33 (0)6 30 93 96 08
e-mail: gilles.audic@novastep-ortho.com |
| Preparation date | May 12th 2015 |
| Trade name | Airlock® osteosynthesis plate system |
|---|---|
| Common Name | Plate, Fixation, Bone |
| Classification Name | Single / Multiple component metallic bone fixation appliances and |
| accessories (21CFR 888.3030, product code HRS) | |
| Regulatory class | II |
| Legally marketed
predicate devices | 510(k) number: K083447
Device name: Anchorage® Bone Plate System
Original applicant: MEMOMETAL TECHNOLOGIES.
This predicate has not been subject to a design-related recall. |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description | Airlock® osteosynthesis plate systems are single-use bone fixation
devices intended to be permanently implanted. Plates are designed with
different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI).
The system uses either 3mm or 3,5mm locking and non-locking screws. |
vastep - Siège Social / Service Client
| n o v a s t e p - S iège Social / Service Client
Espace Performanoe Alphasis - Bâtiment C1-C2 - 35769 SAINT-GRÉGOIRE Cedex - FFRANCE
Tél. +33 (0)2 99 33 86 50 - Fa
Tél. +33 (0)2 99 33 86 50 - Fax: +33 (0)2 30 96 35 61
Code A.P.E.: 3250A - N° SIRET: 752 292 797 00020-N° TVA Intracommunautaire FR 64 752 292 797
4
| | The drill hole are aligned to make sure there is no risk of conflict between
the screws.
The plates vary essentially through different curvatures, lengths, number
of holes and shape. |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Airlock® osteosynthesis plate systems are single use devices intended for
fixation and stabilization of fresh fractures, revision procedures, joint
fusion and reconstruction of small bones of the hand, feet, wrist, ankles,
fingers and toes. The system may be used in both adult and pediatric
patients. |
| Comparison of the
technological
characteristics with the
predicate device | The new devices Airlock® osteosynthesis plate systems plates have similar
technological characteristics in terms of material (ISO5832-3 Implants for
surgery - Metallic material - Part 3: Wrought titanium 6-aluminium 4-
vanadium alloy) and mechanical characteristics (ASTM F382-99 Standard
Specification and Test Methods for Metallic Bone plates) and thus are
believed to be substantially equivalent to the predicate MEMOMETAL
Anchorage® Bone Plate System plates (K083447). |
| | The new devices Airlock® osteosynthesis plate systems screws have
similar technological characteristics in terms of material (ISO5832-3
Implants for surgery - Metallic material - Part 3: Wrought titanium 6-
aluminium 4-vanadium alloy) and mechanical characteristics (ASTM F543-
13 Standard Specification and Test Methods for Metallic Bone screws Part
A1, A2 & A3) and thus are believed to be substantially equivalent to the
predicate MEMOMETAL Anchorage® Bone Plate System screws
(K083447). |
| Performance data | The biocompatibility evaluation for new devices Airlock® osteosynthesis
plate systems was conducted in accordance with Blue Book
Memorandum #G95-1 "Use of International Standard ISO-10993,
'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"
and International Standard ISO 10993-1 "Biological Evaluation of Medical
Devices - Part 1: Evaluation and Testing Within a Risk Management
Process" as recognized by FDA. |
| | The new devices Airlock® osteosynthesis plate systems have similar
technological characteristics in terms of design and mechanical
characteristics and thus are believed to be substantially equivalent to the
predicate MEMOMETAL Anchorage® Bone Plate System (K083447). |
| Indication for use | The Airlock® osteosynthesis plate systems are single use devices indicated
for fixation and stabilization of fresh fractures, revision procedures, joint
fusion and reconstruction of small bones of the hand, feet, wrist, ankles,
fingers and toes. The system may be used in both adult and pediatric
patients. |
| Clinical studies | Clinical studies was not required for this submission |
| Animal Study | Animal Study was not required for this submission
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 |
| Conclusion | The Airlock® osteosynthesis plate systems are substantially equivalent to
their predicate devices MEMOMETAL Anchorage® Bone Plate System
(K083447), in terms of intended use and indications for use, material,
design and function. Any minor differences between these two devices
do not raise new questions of safety and effectiveness. |
vastep - Siège Social / Service Client
| n o v a st e p - Siège Social / Service Client
| Espace Perbrimance Alphasis - Bâtiment C1-C2 - 35769 SAINT-GRÉGOIRE Cedex - FFRANCE
| Tél. +33 (0)2 99 33 86 50 - Fax
Code A.P.E.: 3250A-N° SIRET 752 292 797 00020 - N° TVA Intracommunautaire FR 64 752 292
5
Traditional 510(k) premarket notification
step®
| n o v a s t e p - S iège Social / Service Client
| Espace Performance Alphasis - Bâtiment C1-C2 - 35769 SAINT-GRÉGOIFE Cedex - FFANCE
| Tél. +33 (0)2 99 33 86 50 - F