(170 days)
K 091763
No
The device description and performance studies focus on mechanical properties, surgical procedure, and material biocompatibility. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for "correction of Hallux Valgus deformity," which implies treating or alleviating a medical condition.
No
The device is an implantable system designed to surgically correct Hallux Valgus deformity by reducing the 1st intermetatarsal angle. It facilitates anatomical correction rather than diagnosing a condition.
No
The device description explicitly states it is comprised of an Implant, Accessories, and Instrument Set, which are physical components. The performance studies also focus on mechanical testing, animal tests, and cadaver tests, all related to a physical implant and surgical instruments. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "assist in the correction of Hallux Valgus deformity by providing reduction of the 1st intermetatarsal angle." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is an implantable system comprised of screws, polymeric housing, and sutures. This is a physical device used for mechanical correction within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the CyclaPlex Correction System does not involve any such testing of biological samples.
The device is clearly intended for surgical intervention and correction of a physical deformity, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The CyclaPlex Correction Systemis intended for the following surgical indications: to assist in the correction of Hallux Valgus deformity by providing reduction of the 1st intermetatarsal angle.
Product codes
HTN
Device Description
The CyclaPlex Correction Systemis comprised of the Implant, Accessories and Instrument Set. The Implant device pulls the 1ª metatars al inward to wards 2ª metatars al and reduces the internetatarsal angle to medically accepted values. The implant is comprised of two metallic bone screws with internal polymeric housing connected by UHMW polyethylene multiple sutures cord. The cord is looped at Anchor 2 and secured to Anchor 1 by multiple surgical knots. Tw implants (paired) are implanted to reduce local loads on the bone and reduce loads on the device as well.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 mechanical static and fatigue testing were performed to demonstrate that the proposed device can withstand the biomechanical forces, at least as well as the predicate device. Preclinical animal tests showed that CyclaPlex device performance in minipig animals is at least as good as predicate device Surgical instrument human factor analysis was performed to evaluate the safety and usability of surgical instruments in comparison to predicatedevice, Analysis had demonstrated that instruments provide safe use at least as good as the predicate device.
Cadaver tests further demonstrated that the implant structure, surgery procedure and instruments are suitable to perform implantation as intended. Biological evaluation demonstrated that proposed device materials post manufacturing and cleaning meet ISO 10993-1 requirements. Animal testing further extended the biological safety as sessment as well as demonstrated the device implantation procedure and surgical instrument us ability. Packaging, sterilization and cleaning validation were also conducted for implant and met requirements. MR were performed according ASTM relevant standards (F2119-07, F2052-15, F2182-11a, F2213-06) and included Magnetic field interactions, MR artifacts and MR heating, demonstrating that CyclaPleximplant device is "MR conditional."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K 091763
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cycla Orthopedics Ltd % Elaine Duncan President Paladin Medical PO Box 560 Stilwater, Minnesota 55082-0560 April 26, 2019
Re: K183094
Trade/Device Name: CyclaPlex Correction System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HTN Dated: March 22, 2019 Received: March 26, 2019
Dear Elaine Duncan:
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/cfpm/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Daniel S. Ramsey -S 2019.04.26 12:05:54 -04'00'
FOR Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183094
Device Name
CyclaPlex Correction System
Indications for Use (Describe)
The CyclaPlex Correction System is intended for the following surgical indications: to assist in the correction of Hallux Valgus deformity by providing reduction of the 1st intermetatarsal angle.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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 Druq 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
510(K) SUMMARY- TRADITIONAL-
SUBMITTED on behalf of:
Cycla Orthopedics Ltd. 14 HameyasdimSt. Bat Shlomo, 30992, Israel. Phone 972-4-6443544 Fax 972 3-7256211 Email: info@cycla-or.com
| By: | Elaine Duncan, M.S.M.E., RAC |
|---|---|
| President, Paladin Medical, Inc. | |
| PO Box 560 | |
| Stillwater, MN 55082 | |
| Telephone: | 715-549-6035 |
| Fax: | 715-549-5380 |
| CONTACT PERSON: | Elaine Duncan |
| DATE PREPARED: | October 30, 2018 |
| TRADE NAME: | CyclaPlex Correction System |
| COMMON NAME | Button/Anchor/suture |
| CLASSIFICATION NAME: | Single/multiple component metallic bone fixation appliance |
| and accessories: | |
| CLASS | CLASS II |
| REGULATION/PROCODE | 21 CFR 888.3030/ PRO CODE: HTN |
INDICATIONS FOR USE:
The CyclaPlex Correction Systemis intended for the following surgical indications: to assist in the correction of Hallux Valgus deformity by providing reduction of the 1st intermetatarsal angle.
DESCRIPTION of the DEVICE:
The CyclaPlex Correction Systemis comprised of the Implant, Accessories and Instrument Set. The Implant device pulls the 1ª metatars al inward to wards 2ª metatars al and reduces the internetatarsal angle to medically accepted values. The implant is comprised of two metallic bone screws with internal polymeric housing connected by UHMW polyethylene multiple sutures cord. The cord is looped at Anchor 2 and secured to Anchor 1 by multiple surgical knots. Tw implants (paired) are implanted to reduce local loads on the bone and reduce loads on the device as well.
SUBSTANTIALLY EQUIVALENT TO:
The CyclaPlex Correction Systemis substantially equivalent to Instratek-Michelangelo Bunion System (MAB). Premarket notification: K 091763. MAB is comprised of two buttons/plates connected by UHMW polyethylene cord. The CyclaPlex Correction Systemis the same as the predicate device in areas of classification, anatomical site, where used, principle of operation, intended use, contraindications and material: both utilize UHM WPE suture and two metallic end caps, both intended for use in the same anatomical location. CyclaPlexhas slight differences in strumentation and sterilization. Additional differences include the end cap geometry, a more modular design with a polymeric insert. Also, the CyclaPlex requires two implants whereas the predicate allows various configurations (one or more).
4
510(k) Summary-Continued
A detailed analysis and testing have demonstrated that the CyclaPlexCorrection Systemhas the same raises no new safety or effectiveness questions.
SUMMARY of TESTING to DEMONSTRATE SAFETY and EQUIVALENCE:
The mechanical static and fatigue testing were performed to demonstrate that the proposed device can withstand the biomechanical forces, at least as well as the predicate device. Preclinical animal tests showed that CyclaPlex device performance in minipig animals is at least as good as predicate device Surgical instrument human factor analysis was performed to evaluate the safety and usability of surgical instruments in comparison to predicatedevice, Analysis had demonstrated that instruments provide safe use at least as good as the predicate device.
Cadaver tests further demonstrated that the implant structure, surgery procedure and instruments are suitable to perform implantation as intended. Biological evaluation demonstrated that proposed device materials post manufacturing and cleaning meet ISO 10993-1 requirements. Animal testing further extended the biological safety as sessment as well as demonstrated the device implantation procedure and surgical instrument us ability. Packaging, sterilization and cleaning validation were also conducted for implant and met requirements. MR were performed according ASTM relevant standards (F2119-07, F2052-15, F2182-11a, F2213-06) and included Magnetic field interactions, MR artifacts and MR heating, demonstrating that CyclaPleximplant device is "MR conditional."
CONCLUSION:
Based upon the comparative analysis and testing the CyclaPlex Correction Systemis substantially equivalent to the currently marketed predicate device.