(204 days)
Not Found
No
The submission focuses solely on adding MR Conditional labeling to existing devices based on non-clinical MRI testing, with no mention of AI or ML.
No
The submission states its purpose is to add MR Conditional information to the labeling for predicate devices. It also mentions that the addition of MR labeling does not impact indications. The predicate devices listed are internal fixation systems and fusion systems, which are intended to provide structural support rather than directly treat or cure a disease or condition. The document describes testing for MR compatibility and safety, not for therapeutic efficacy.
No
The submission explicitly states that "The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization." This indicates that the device's original purpose (diagnostic or otherwise) is not being changed by this submission, which is solely focused on MR compatibility. The provided text does not define the original intended use of the devices, only that this submission is about adding MR Conditional information, which is a safety and compatibility update for existing devices, not a new diagnostic function.
No
The submission describes the addition of MR Conditional information to the labeling of existing predicate devices, which are identified as "passive implant devices" and "internal fixation system" and "implant". The testing performed relates to the physical interaction of these devices with an MRI environment, indicating they are hardware implants, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text states the intended use remains the same as previously cleared predicate devices. While the specific intended use isn't detailed here, the context of adding MR Conditional information to labeling for existing devices strongly suggests these are implantable or external medical devices used in vivo (within the body) or on the body, not for testing samples in vitro (outside the body).
- Device Description: The purpose is to add MR Conditional information to labeling. This is relevant for devices that will be in or near a patient during an MRI scan, which are typically not IVDs.
- Input Imaging Modality: The input imaging modality is Magnetic Resonance Imaging (MRI). MRI is used to image the inside of the body, not to analyze samples in a lab.
- Anatomical Site: The anatomical sites mentioned (feet, hands, ankle joint, etc.) are parts of the human body, not samples for laboratory testing.
- Performance Studies: The performance studies described are related to the safety and compatibility of the device in an MRI environment (displacement force, torque, heating, image artifact). These are relevant for devices that will be in or near a patient during an MRI, not for IVDs which analyze samples.
- Predicate Devices: The predicate devices listed are various types of surgical implants and fixation systems (fusion systems, plates, screws, etc.). These are all examples of medical devices used in vivo, not IVDs.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The information provided in the text clearly describes a device that interacts with the human body directly, not a device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The DigiFuse® implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers. Indications include: · Hammer toe deformity - · Claw toe deformity - · Mallet toe deformity · Other deformities of the feet and hands The DigiFuse® implants are intended for single use only.
Integra(r) total foot system is indicated for skeletally mature patients for the following: -stabilization and fixation of fresh fractures -intra and extra articular fractures, joint depression, and multi-fragmentary fractures -revision procedures, joint fusion, and reconstruction of small bones of the feet.
The indications for use for the Integra® CAPTURE™ Screw System are as follows: "The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses, and osteotomies of the hand and foot. The implants are intended for single use only.
The indications for use for the Integra® Ti6® Internal Fixation System are as follows: "The Ti6® Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
The Subtalar MBA System is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. *Severely pronated foot *Walking intemperence - *Calcaneal stance position great than 5 degrees *Manually correctable deformities *Mid-tarsal breech (arch pain) *Forefoot varus greater than 10 degrees
The metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and meical displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Indications include: severe pronation Calcaneal valgus deformity plantarflexed talus failed correction with long term orthotic treatment congenital and painful flatfoot deformity repair of tarsal coalitions subtalar instability posterior tibial tendon dysfunction paralytic flat foot deformity. The metasurg subtalar implants are intended for single use only.
The "new" bold screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include: - fixation of small bone fragments, in long bones or small bones fractures. - arthrodesis in hand or foot surgery - mono or bi-cortical osteotomies in the foot or hand - distal or proximal metatarsal or metacarpal osteotomies - fixation of osteotomies for hallux valgus treatment (such as scarf, chevron, etc.)
The hallu lock plates are intended for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Including cases of: hallux rigidus severe hallux valgus (im angle>20 degrees and hv angle >40 degrees) deformity from rheumatoid arthritis failed previous surgical procedures traumatic arthritis neuromuscular instability the hallu lock plates must be fixed with tixed angle locking system and with the surfix-alpha variable angle locking system of 2.7mm or 3.0mm diameter (scews and lock-screws). Addition of a newdeal quix screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
The hallu plates are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metastarsophalangeal joint, including cases of: hallux rigidus severe hallux valgus (im angle > 20 degree and hv angle >40 degree) deformity from rheumatoid arthritis failed previous surgical procedure traumatic arthritis neuromuscluar instability The plates have to be fixed with the snap-off screws. Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
The quix positioning screw is indicated for fixation of bone reconstruction. Examples include: - * mono or bi-cortical osteotomies in the foot or hand (including hallux valgus treatment) - * fractures management in the foot or hand - * fixation of bone fragments in long bones or small bones fractures - *arthrodesis in hand, foot and ankle surgery The size of the chosen screw should be adapted to the specific indication.
The "new" spin" snap-off screw is indicated for fixation of bone fractures of for bone reconstruction. Examples include: - fixation of small bone fragments - weil osteomy - mono-cortical fixation - osteotomies and fractures fixation in the foot and hand.
The Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal TIBIAXYS Plates have to be fixed with the SURFIX and SURFIX ALPHA 3.5mm diameter Locking System (screws and Lock screws). Anterior plates for ankle Arthrodesis have to be fixed with the TIBIAXYS 4.0mm diameter cortical
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The purpose of this submission is the addition of MR Conditional information to the labeling for the predicate devices. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions, packaging or sterilization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lesser phalanges (toes and fingers), small bones of the feet, hand and foot, subtalar joint, ankle joint, distal tibia and fibula.
Indicated Patient Age Range
Skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
Non-clinical Magnetic Resonance Imaging (MRI) testing performed on the devices determined the devices are MR conditional in accordance with ASTM F2503 (Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment) and FDA Guidance (Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment). MR Testing addressed the following: 1. Magnetically Induced Displacement Force (ASTM F2052) 2. Magnetically Induced Toque (ASTM F2213) 3. RF-induced heating (ASTM F2182) 4. Image Artifact (ASTM F2119).
The completed MR compatibility testing establishes the conditional safety and compatibility of the passive implant devices in the MR environment, and the addition of MR Conditional labeling.
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.
K152527, K123000, K162153, K960692, K111265, K011262, K083154, K093781, K071639, K011946, K073375
Reference Device(s):
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 27, 2021
Integra Lifesciences Corporation Blesson Abraham Senior Regulatory Affairs Specialist 11101 Metric Blvd Austin, Texas 78758
Re: K210016
Trade/Device Name: Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw.NewDeal TIBIAXYS 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, HWC Dated: June 18, 2021 Received: June 22, 2021
Dear Blesson Abraham:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K210016
Device Name
Integra DigiFuse Cannulated Intramedullary Fusion System,Integra CAPTURE Screw System & Integra Tí6 Internal Fixation System,Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System.
Indications for Use (Describe)
The DigiFuse® implant is indicated for the fixation
of osteotomies and reconstruction of the lesser
phalanges during procedures to correct deformities of the toes and fingers.
Indications include:
· Hammer toe deformity
- · Claw toe deformity
- · Mallet toe deformity
· Other deformities of the feet and hands
The DigiFuse® implants are intended for single use only.
Integra(r) total foot system is indicated for skeletally mature patients for the following:
-stabilization and fixation of fresh fractures
-intra and extra articular fractures, joint depression, and multi-fragmentary fractures
-revision procedures, joint fusion, and reconstruction of small bones of the feet.
The indications for use for the Integra® CAPTURE™ Screw System are as follows: "The CAPTURE™ Screw System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses, and osteotomies of the hand and foot. The implants are intended for single use only.
The indications for use for the Integra® Ti6® Internal Fixation System are as follows: "The Ti6® Internal Fixation System implants (screws) are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot. The implants are intended for single use only.
The Subtalar MBA System is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela.
*Severely pronated foot
*Walking intemperence
- *Calcaneal stance position great than 5 degrees
*Manually correctable deformities
*Mid-tarsal breech (arch pain)
*Forefoot varus greater than 10 degrees
The metasurg subtalar implant is indicated for use in the treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block forward, downward and meical displacement of the talus, thus allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Indications include: severe pronation Calcaneal valgus deformity plantarflexed talus failed correction with long term orthotic treatment congenital and painful flatfoot deformity repair of tarsal coalitions subtalar instability
3
posterior tibial tendon dysfunction
paralytic flat foot deformity
The metasurg subtalar implants are intended for single use only.
The "new" bold screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- fixation of small bone fragments, in long bones or small bones fractures.
- arthrodesis in hand or foot surgery
- mono or bi-cortical osteotomies in the foot or hand
- distal or proximal metatarsal or metacarpal osteotomies
- fixation of osteotomies for hallux valgus treatment (such as scarf, chevron, etc.)
The hallu lock plates are intended for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Including cases of:
hallux rigidus
severe hallux valgus (im angle>20 degrees and hv angle >40 degrees)
deformity from rheumatoid arthritis
failed previous surgical procedures
traumatic arthritis
neuromuscular instability
the hallu lock plates must be fixed with tixed angle locking system and with the surfix-alpha variable angle locking system of 2.7mm or 3.0mm diameter (scews and lock-screws). Addition of a newdeal quix screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
The hallu plates are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metastarsophalangeal joint, including cases of:
hallux rigidus
severe hallux valgus (im angle > 20 degree and hv angle >40 degree)
deformity from rheumatoid arthritis
failed previous surgical procedure
traumatic arthritis
neuromuscluar instability
The plates have to be fixed with the snap-off screws. Addition of a screw crossing the joint is strongly recommended for optimal arthrodesis consolidation.
The quix positioning screw is indicated for fixation of bone reconstruction. Examples include:
-
- mono or bi-cortical osteotomies in the foot or hand (including hallux valgus treatment)
-
- fractures management in the foot or hand
-
- fixation of bone fragments in long bones or small bones fractures
- *arthrodesis in hand, foot and ankle surgery
The size of the chosen screw should be adapted to the specific indication.
The "new" spin" snap-off screw is indicated for fixation of bone fractures of for bone reconstruction. Examples include:
- fixation of small bone fragments
- weil osteomy
- mono-cortical fixation
- osteotomies and fractures fixation in the foot and hand.
The Newdeal TIBIAXYS System is indicated for fixation of bone fractures or for bone reconstruction including Arthrodesis, Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal TIBIAXYS Plates have to be fixed with the SURFIX and SURFIX ALPHA 3.5mm
diameter Locking System (screws and Lock screws).
Anterior plates for ankle Arthrodesis have to be fixed with the TIBIAXYS 4.0mm diameter cortical
4
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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5
510(k) Summary
| Sponsor | Ascension Orthopedics, Inc.
11101 Metric Blvd.
Austin, TX 78758 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Number | 3014207283 |
| Point of Contact | Blesson Abraham
11101 Metric Blvd.
Austin, TX 78758 |
| Date | June 18, 2021 |
| Trade Name | This 510(k) applies to multiple product lines, as identified below, as this is a
bundled 510(k) per FDA Guidance Document, Bundling Multiple Devices or
Multiple Indications in a Single Submission .
- Integra DigiFuse Cannulated Intramedullary Fusion System
- Integra Total Foot System
- Integra Capture Internal Fixation System & Integra Ti6 Internal Fixation System
- Subtalar MBA System
- MetaSurg Subtalar Implant
- NewDeal BOLD Screw
- New HALLU Lock Plate System
- NewDeal HALLU Plates
- QWIX Positioning Screw
- SPIN Snap-Off Screw
- NewDeal TIBIAXYS System |
| Common Name | 1. Cannulated Intramedullary Fusion System - Plate, Fixation, Bone
- Bone Screw
- Subtalar Arthrorisis Implant
- Subtalar Arthrorisis Implant
- Bone Fixation Screw, Cannulated Compression Screw
- Plate, Fixation, Bone
- Plate, Fixation, Bone
- Bone Fixation Screw
- Bone Fixation Screw, Self-Drilling and Self-Tapping Snap-Off Screw
- Plate, Fixation, Bone |
| Classification Name | 1. HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) - HRS – Single/multiple component metallic bone fixation appliances and
accessories (21 CFR 888.3030) - HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
- HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
- HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
- HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)
- HRS – Single/multiple component metallic bone fixation appliances and
accessories (21 CFR 888.3030) - HRS – Single/multiple component metallic bone fixation appliances and
accessories (21 CFR 888.3030) - HWC – Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| | 10. HWC - Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) - HRS - Single/multiple component metallic bone fixation appliances and
accessories (21 CFR 888.3030) |
| Classification | Class II |
| Predicate
Device | Primary Predicate - K152527 - Integra DigiFuse Cannulated Intramedullary Fusion System
Additional predicates are as follows and identified with the corresponding reference
from the previous sections of this 510(k) summary. - K123000 - Integra Total Foot System
- K162153 – Integra Capture Internal Fixation System & Integra Ti6 Internal
Fixation System - K960692 – Subtalar MBA System
- K111265 – MetaSurg Subtalar Implant
- K011262 - NewDeal BOLD Screw
- K083154 - NewDeal HALLU Lock Plate System
- K093781 - NewDeal HALLU Plates
- K071639 – QWIX Positioning Screw
- K011946 - SPIN Snap-Off Screw
- K073375 - NewDeal TIBIAXYS System |
| Classification
Panel | Orthopedic |
| Device
Description | The purpose of this submission is the addition of MR Conditional information to the
labeling for the predicate devices. The addition of MR labeling to the subject
devices does not impact indications, materials, design features or dimensions,
packaging or sterilization. |
| Intended Use/
Indications for
Use | The intended use/indications for use of the predicate devices identified remain the
same as previously cleared in their respective 510(k)s. The respective 510(k)s for
the devices can be referenced in the predicate device section above. |
| Nonclinical
Performance
Data | Non-clinical Magnetic Resonance Imaging (MRI) testing performed on the devices
determined the devices are MR conditional in accordance with ASTM F2503
(Standard Practice for Marking Medical Devices and Other Items for Safety in the
Magnetic Resonance Environment) and FDA Guidance (Establishing Safety and
Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment).
MR Testing addressed the following: - Magnetically Induced Displacement Force (ASTM F2052)
- Magnetically Induced Toque (ASTM F2213)
- RF-induced heating (ASTM F2182)
- Image Artifact (ASTM F2119) |
| Conclusion | The completed MR compatibility testing establishes the conditional safety and
compatibility of the passive implant devices in the MR environment, and the
addition of MR Conditional labeling. |
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