(120 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical implant for sternal stabilization. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a sternal stabilization system intended for mechanical closure and stabilization of the sternum to promote fusion, rather than to treat or cure a disease or condition itself.
No
The device is an implantable mechanical system used for stabilizing the sternum after surgery, not for diagnosing a condition.
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 PEEK-OPTIMA™ or carbon-fiber reinforced PEEK-OPTIMA™. This is a hardware device, not software.
Based on the provided information, the STERN FIX Sternal Stabilization System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion." This describes a surgical implant used to physically support and stabilize bone, not a device used to examine specimens derived from the human body for diagnostic purposes.
- Device Description: The description details a "long-term implantable postoperative sternal stabilization system" consisting of physical components (male and female parts, curved arms) made of specific materials. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the STERN FIX Sternal Stabilization System is a surgical implant, not an IVD.
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
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. The predicate device was originally made of PEEK-OPTIMA™. This 510(k) introduces a new variant of the product made of carbon-fiber reinforced (CFR) PEEK-OPTIMA™. This new variant also presents some minor geometry changes with respect to the predicate device, to adapt the product to the new material.
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
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: - 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.
No clinical testing was performed to support this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
October 19, 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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Neos Surgery SL % Cherita James Regulatory Consultant M Squared Associates, Inc. 127 West 30th Street. 9th Floor New York, New York 10001
Re: K221795
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: July 21, 2022 Received: July 22, 2022
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
1
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 mediation-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,
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
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Indications for Use
510(k) Number (if known) K221795
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
The following information is provided as required by 21 CFR § 807.87 for the STERN FIX Sternal Stabilization System Traditional 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.
- Sponsor: Neos Surgery S.L. Parc Tecnològic del Vallès C/Ceramistes, 2 08290 Cerdanyola del Vallès Barcelona, Spain
- Cherita James Contact: 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: June 16, 2022 Proprietary Name: STERN FIX Sternal Stabilization System Common Name: Cerclage, fixation Regulatory Class: II Regulation: 888.3010 Bone fixation cerclage Product Codes: JDQ Primary Predicate Device(s): STERN FIX Sternal Stabilization System - K211613
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
4
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. The predicate device was originally made of PEEK-OPTIMA™. This 510(k) introduces a new variant of the product made of carbon-fiber reinforced (CFR) PEEK-OPTIMA™. This new variant also presents some minor geometry changes with respect to the predicate device, to adapt the product to the new material.
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.
| Device | STERN FIX
(Current product, cleared in K211613) | STERN FIX
(Modified) |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | NEOS Surgery S.L. | NEOS Surgery S.L. |
| 510(k) No. | K211613 | Present document |
| Product Code | JDQ- Cerclage, Fixation | Same |
| 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. | Same |
| 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. | Same |
| Device | STERN FIX
(Current product, cleared in K211613) | STERN FIX
(Modified) |
| 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 an application tool.
The STERN FIX can be cut and removed for emergent, and long-term, re-entry through the sternum. | Same |
| Range of sternum thicknesses and widths covered | Thickness: From 9.5 to 17 mm
Width: From 17 to 38 mm | Same |
| 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. | Besides the four instruments already included in the cleared version of the product (SCI0000, SCI0501, SCI0200, SCI0300), a new alternate cutter (SCI0700) is added. This instrument may be used as an alternative to SCI0200, if preferred by the user, to cut the excess segment of the male part. |
| Material Composition | PEEK-OPTIMA™ LT3, according to ASTM F2026 | PEEK-OPTIMA™ LT1CA30, according to ASTM F3333-20 |
| 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. | Same |
| Implant life | Long-term implant | Same |
Technological characteristics, comparison to predicate device
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Technological Characteristics and Substantial Equivalence
The changes proposed for the modified STERN FIX do not change the indications for use of the original product, nor its contraindications, potential side effects or adverse events. The group of users and the use environment also remain unchanged. The material change does not imply any
6
new or increased biocompatibility concerns, based on the risk assessment performed. The changes on the geometry do not modify the critical dimensions of the product, nor do they imply a modification of the design requirements or the final product specifications. Similarly, the sternum thickness and width range for which the device can be used, as well as the implantation method, remain the same. Finally, the addition of a new accessory (SCI0700) does not affect the directions of use nor the implantation method of the device.
In summary, the modified STERN FIX is substantially equivalent to its predicate device with regards to indications for use, technological characteristics, principles of operation and performance.
Performance testing
Performance testing was conducted to characterize the capacity of the modified 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 the modified STERN FIX do not raise any new safety or effectiveness issues and that it 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 | |
| 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. |
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| 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:
| Standard | Recognition
Number |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| ISO 14971 Third edition 2019-012: Medical devices - Application of risk
management to medical devices | 5-125 |
| 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 1.1 2020-06 CONSOLIDATED VERSION:
Medical devices - Part 1: Application of usability engineering to medical
devices [Including CORRIGENDUM 1 (2016)] | 5-129 |
| 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 |
| 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 - | 14-540 |
| Standard | Recognition
Number |
| Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process | |
| 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 Fourth edition 2021-07: Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements | 5-134 |
| 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 comparison of the intended use (based on the indications for use), product technical characteristics, principles of operation and performance, the modified STERN FIX has demonstrated substantial equivalence to the previously cleared STERN FIX product. The differences do not raise new issues of safety or effectiveness, based on the risk assessment
9
performed and on the results of the verification / validation activities that have been conducted.