(238 days)
Not Found
No
The description focuses on the mechanical function and performance of a physical sternal stabilization device, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device is described as a "long-term implantable postoperative sternal stabilization system" intended for "closure and stabilization of the sternum following sternotomy... in order to promote its fusion," which directly relates to treating a medical condition and facilitating healing.
No
Explanation: The device is a sternal stabilization system used for closure and stabilization of the sternum after sternotomy to promote fusion, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "long-term implantable postoperative sternal stabilization system" consisting of physical components (male and female parts, curved arms) made of material, which are implanted into the body. This is a hardware medical device, not software.
Based on the provided information, the STERN FIX Sternal Stabilization System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the closure and stabilization of the sternum following sternotomy to promote fusion. This is a surgical procedure performed on the patient's body.
- Device Description: The device is described as a "long-term implantable postoperative sternal stabilization system" and a "clamping device." These are physical implants used to mechanically stabilize bone.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status. The STERN FIX does not interact with biological specimens in this way.
- Performance Studies: The performance studies described (breaking strength, fatigue, biomechanical, cadaver testing) are focused on the mechanical properties and surgical application of the device, not on analyzing biological samples.
Therefore, the STERN FIX is a surgical implant/device used for mechanical stabilization, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion.
Product codes (comma separated list FDA assigned to the subject device)
JDQ
Device Description
The STERN FIX is a long-term implantable postoperative sternal stabilization system that closes and stabilizes the sternum after a sternotomy. The STERN FIX is a clamping device consisting of two parts, male and female, which match telescopically with one another to form the sternal stabilization system. Both male and female parts have a curved arm that catches one of the two halves of the sternum laterally and approximates them until the sternum is securely fixed. Five sizes of the STERN FIX are available for use with different sternum thicknesses. The STERN FIX can be cut and removed for emergent, and long-term, re-entry through the sternum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternum
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)
Performance testing was conducted to characterize the capacity of the STERN FIX, as a sternal stabilization system, to withstand the forces that act upon the sternum and the whole fixation system once the products have been implanted. The results of the tests confirm the adequate performance of the device, and that it is able to achieve its intended use.
Performance testing has demonstrated that the technological characteristics of STERN FIX do not raise any new safety or effectiveness issues and that the STERN FIX will perform as intended in the clinical setting. A summary of the tests performed follows:
Test: Functional testing
Results: Breaking strength - All tested samples meet the specifications. Functionality of the devices is demonstrated.
Results: Fatigue test - All tested samples meet the specifications. Functionality of the devices is demonstrated.
Test: Biomechanical testing
Results: Breaking strength - All tested samples meet the specifications. The STERN FIX system has an adequate biomechanical behavior when subject to relevant efforts.
Results: Lateral distraction test - All tested samples meet the specifications. The STERN FIX system has an adequate biomechanical behavior when subject to relevant efforts.
Results: Cadaver testing - Correct devices implantation is verified in a simulated real-life situation. The devices show adequate performance and safety.
No clinical testing was performed to support this submission.
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
0
February 10, 2022
Image /page/0/Picture/1 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Neos Surgery S.L. % Cherita James Regulatory Consultant M Squared Associates, Inc 127 West 30th Street, 9th Floor New York, New York 10001
Re: K211613
Trade/Device Name: Stern Fix Sternal Stabilization System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ
Dear Cherita James:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated January 19, 2022. Specifically, FDA is updating this SE Letter to correct a typographical error in the sponsor name as an administrative correction and to include the full indications for use form.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Colin O'Neill, M.B.E., OHT6: Office of Orthopedic Devices, (301) 796-6428, colin.oneill(@fda.hhs.gov.
Sincerely,
Anne D. Talley -S
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
January 19, 2022
Image /page/1/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The FDA is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products.
Neoss Surgery SL % Cherita James Regulatory Consultant M Squared Associates, Inc 127 West 30th Street, 9th Floor New York, New York 10001
Re: K211613/S001
Trade/Device Name: Stern Fix Sternal Stabilization System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ Dated: December 16, 2021 Received: December 20, 2021
Dear Cherita James:
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.
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
2
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 (QS) 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Anne D. Talley -S for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
Device Name
STERN FIX, Sternal Stabilization System
Indications for Use (Describe)
The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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5
510(K) SUMMARY
The following information is provided as required by 21 CFR § 807.87 for the STERN FIX Sternal Stabilization System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
- Neos Surgery S.L. Sponsor: Parc Tecnològic del Vallès C/Ceramistes. 2 08290 Cerdanyola del Vallès Barcelona, Spain
- Contact: Cherita James M Squared Associates. Inc. 127 West 30th Street, 9th Floor New York, New York 10001 Ph: 347-954-0624 Fax: 703-562-9797 Email: Cjames@MSquaredAssociates.com
Date of Submission: December 16, 2021
Proprietary Name: STERN FIX Sternal Stabilization System
Common Name: Cerclage, fixation
Regulatory Class: II
Regulation: 888.3010 Bone fixation cerclage
Product Codes: JDQ
Predicate Device(s): SYNTHES STERNAL ZIPFIX SYSTEM - K110789 KLS MARTIN STERNAL TALON- K051165 Reference Device:
Device Description
The STERN FIX is a long-term implantable postoperative sternal stabilization system that closes and stabilizes the sternum after a sternotomy. The STERN FIX is a clamping device consisting of two parts, male and female, which match telescopically with one another to form the sternal stabilization system. Both male and female parts have a curved arm that catches one of the two
6
halves of the sternum laterally and approximates them until the sternum is securely fixed. Five sizes of the STERN FIX are available for use with different sternum thicknesses. The STERN FIX can be cut and removed for emergent, and long-term, re-entry through the sternum.
Indications for Use
The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion.
| Technological characteristics, comparison to predicate and reference devices. | |||
|---|---|---|---|
| Device | STERN FIX | ZIPFIX | |
| (Predicate device) | Sternal Talon | ||
| (Reference device) | |||
| Company | NEOS Surgery S.L. | Synthes | KLS Martin, L.P. |
| 510(k) No. | Present submission | K110789 | K051165 |
| Product Code | JDQ- Cerclage, Fixation | JDQ- Cerclage, Fixation | HRS- Plate, Fixation, Bone |
| Indications for Use | The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion. | The Synthes Sternal ZIPFIXTM system is intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion. | |
| (Description of the “Intended use” in the 510(k) Summary) | The KLS-Martin Sternal Talon is intended for use in stabilization and fixation of anterior chest wall fractures including Sternal Fixation subsequent to Sternotomy and Sternal reconstructive procedures. | ||
| (Description of the “Intended use” in the 510(k) Summary) | |||
| Method of Fixation to Sternum | Peristernally, through the intercostal spaces. Generally, 5 STERN FIX devices are recommended per median sternotomy closure, but they can be used in combination with other sternal closure systems such as wires or plates. | Similar method | Similar method |
| Device | |||
| Design | The STERN FIX device | ||
| consists of two parts, male | |||
| and female, which match | |||
| telescopically with one | |||
| another to form the fixation | |||
| system. Both male and | |||
| female parts have a curved | |||
| arm that catches laterally one | |||
| of the two halves of the | |||
| sternum and approximates | |||
| them until the sternum is | |||
| securely fixed. Both parts | |||
| present a set of teeth that, | |||
| together, form a ratchet | |||
| mechanism that allows their | |||
| movement in the closing | |||
| direction and, at the same | |||
| time, impedes their backward | |||
| movement. The tightening of | |||
| both implant parts (male and | |||
| female) is carried out using | |||
| the specific instrument | |||
| supplied with the product. | |||
| The STERN FIX can be cut | |||
| and removed for emergent, | |||
| and long-term, re-entry | |||
| through the sternum. | Similar design | Similar design | |
| Range of | |||
| sternum | |||
| thicknesses | |||
| and widths | |||
| covered | Thickness: From 9.5 to 17 | ||
| mm | |||
| Width: From 17 to 38 mm | Similar | similar | |
| Accessories | Four instruments are used to | ||
| implant the device: | |||
| • A depth gauge (SCI0000) | |||
| to select the appropriate | |||
| STERN FIX size. | |||
| • Forceps (SCI0501) to | |||
| tighten and adjust the | |||
| STERN FIX during its | |||
| implantation. | |||
| • A cutter (SCI0200) to cut | |||
| the excess segment of the | |||
| male part or cut the device | |||
| safely in case of need of | |||
| device removal. | |||
| • A retractor (SCI0300) to | |||
| ease the introduction of | |||
| the STERN FIX in the | |||
| intercostal spaces. | similar tools | similar tools | |
| Material | |||
| Composition | PEEK- OPTIMA™ LT3, | ||
| according to ASTM F2026 | similar materials | Similar materials | |
| Sizes | Five sizes that allow | ||
| implantation in sternal bones | |||
| of all thicknesses considered | |||
| (from 9.5 mm to 17 mm). Its | |||
| length can be adjusted to fit | |||
| each sternal bone width by | |||
| cutting the excess segment of | |||
| the male part. | Similar sizes | Similar sizes | |
| Implant life | Long-term implant | Long-term implant | Long-term implant |
| Sterility | Provided sterile. E-beam | similar | similar |
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Technological Characteristics and Substantial Equivalence
The STERN FIX is substantially equivalent to its predicate device with regards to indications for use, technological characteristics, principles of operation and performance. The technical differences found between the STERN FIX and its predicate do not raise different questions of safety and effectiveness. These differences have been discussed and justified with the use of the reference device.
Performance testing
Performance testing was conducted to characterize the capacity of the STERN FIX, as a sternal stabilization system, to withstand the forces that act upon the sternum and the whole fixation system once the products have been implanted. The results of the tests confirm the adequate performance of the device, and that it is able to achieve its intended use.
Performance testing has demonstrated that the technological characteristics of STERN FIX do not raise any new safety or effectiveness issues and that the STERN FIX will perform as intended in the clinical setting. A summary of the tests performed follows:
| Test | Conclusions |
|---|---|
| Functional testing | |
| Breaking strength | All tested samples meet the specifications. Functionality |
| of the devices is demonstrated. | |
| Fatigue test | All tested samples meet the specifications. Functionality |
| of the devices is demonstrated. | |
| Biomechanical testing |
9
| Breaking strength | All tested samples meet the specifications. The STERN
FIX system has an adequate biomechanical behavior
when subject to relevant efforts. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Lateral distraction test | All tested samples meet the specifications. The STERN
FIX system has an adequate biomechanical behavior
when subject to relevant efforts. |
| Cadaver testing | Correct devices implantation is verified in a simulated
real-life situation. The devices show adequate
performance and safety. |
Conformance to Standards
The STERN FIX Sternal Stabilization System is in conformance to the following recognized consensus standards: and the comments of the comments of the comments of the comments of the comments of the comments of the contraction of the contraction of the contribution of the contribution
| Standard | Recognition
Number |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| ISO 14971 Second edition 2007-03-01: Medical devices - Application of
risk management to medical devices | 5-40 |
| ISO 14630 Fourth edition 2012-12-01: Non-active surgical implants --
General requirements | 11-254 |
| ISO 11607-1 Second edition 2019-02: Packaging for terminally sterilized
medical devices - Part 1: Requirements for materials, sterile barrier
systems and packaging systems | 14-530 |
| ISO 11607-2 Second edition 2019-02: Packaging for terminally sterilized
medical devices - Part 2: Validation requirements for forming, sealing
and assembly processes | 14-531 |
| IEC 62366-1 Edition 1.0 2015-02: Medical devices - Part 1: Application
of usability engineering to medical devices [Including CORRIGENDUM
1 (2016)] | 5-114 |
| ISO 11137-1 First edition 2006-04-15: Sterilization of health care
products - Radiation - Part 1: Requirements for development, validation
and routine control of a sterilization process for medical devices
[Including: Amendment 1 (2013) and Amendment 2 (2018)] | 14-528 |
| Standard | Recognition
Number |
| ISO 11137-2 Third edition 2013-06-01: Sterilization of health care
products - Radiation - Part 2: Establishing the sterilization dose | 14-409 |
| ISO 11737-1 Third edition 2018-01: Sterilization of health care products
- Microbiological methods - Part 1: Determination of a population of
microorganisms on product | 14-514 |
| ISO 11737-2 Third edition 2019-12: Sterilization of medical devices -
Microbiological methods - Part 2: Tests of sterility performed in the
definition, validation and maintenance of a sterilization process | 14-540 |
| ISO 10993-1 Fifth edition 2018-08 Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk management process | 2-258 |
| ISO 10993-5 Third edition 2009-06-01: Biological evaluation of medical
devices - Part 5: Tests for in vitro cytotoxicity | 2-245 |
| ISO 15223-1 Third Edition 2016-11-01: Medical devices - Symbols to be
used with medical device labels, labelling, and information to be supplied - Part 1: General requirements | 5-117 |
| ISO 17665-1 First edition 2006-08-15: Sterilization of health care
products - Moist heat - Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical
devices | 14-333 |
| ISO 17664 Second edition 2017-10: Processing of health care products -
Information to be provided by the medical device manufacturer for the
processing of medical devices | 14-515 |
| ASTM F2026-17: Standard Specification for Polyetheretherketone
(PEEK) Polymers for Surgical Implant Applications | 8-475 |
| ASTM F2503-20: Standard Practice for Marking Medical Devices and
Other Items for Safety in the Magnetic Resonance Environment | 8-528 |
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Discussion of clinical testing
No clinical testing was performed to support this submission.
Conclusion
Based on the design features, the use of an established well-known biocompatible material, the intended use, the technological characteristics and the principles of operation, the subject device has demonstrated substantial equivalence to the identified legally marketed predicate device. The technical differences do not raise new issues of safety or effectiveness, based on the comparison with the identified legally marketed reference device.
The results of the performance testing demonstrate that the subject device meets its specifications and fulfills its intended use.