(469 days)
No
The summary describes a mechanical bone staple made of Nitinol and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is used for "osteotomy fixation and joint arthrodesis," which are therapeutic procedures to fix bone fragments and fuse joints, respectively.
No
Explanation: The device is a bone staple system used for fixation and arthrodesis, which are treatment procedures, not diagnostic ones.
No
The device description explicitly states it includes "superelastic bone staples shape memory Nitinol," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "hand and foot bone fragments osteotomy fixation and joint arthrodesis." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "superelastic bone staples." This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used to fix bones.
N/A
Intended Use / Indications for Use
The EasyClip® staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis in adults and pediatrics (children and adolescents).
The EasyClip® Xpress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis in adults and pediatrics (children and adolescents).
Product codes
JDR
Device Description
The EasyClip® & EasyClip® Xpress, previously cleared in K122113 and K162321, includes superelastic bone staples shape memory Nitinol per ASTM F2063-18. The subject of the bundled submission introduces a contraindication for both systems and packaging change for EasyClip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot
Indicated Patient Age Range
adults and pediatrics (children and adolescents)
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)
Non-Clinical Performance and Conclusions:
Packaging, biocompatibility and corrosion tests were performed according to ISO 11607-1 and ISO 11607-2, ISO 10993 and ASTM F2129, respectively.
All bench tests performed in accordance with ASTM standards and previously presented in EasyClip® and EasyClip® Xpress. K122113 and K162321, respectively, remains true and accurate.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized symbol. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
June 10, 2022
Stryker GmbH Danielle Madureira Staff Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
Re: K210582
Trade/Device Name: EasyClip® and EasyClip® Xpress Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDR Dated: June 3, 2022 Received: June 6, 2022
Dear Danielle Madureira:
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
1
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 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,
Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name EasyClip®
Indications for Use (Describe)
The EasyClip@ staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis in adults and pediatrics (children and adolescents).
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| Reproductive Use (Part 21 CFR 601.21 Subpart D) One-Time Contact Use (21 CFR 601.21 Subpart E) | Reproductive Use (Part 21 CFR 601.21 Subpart D) | One-Time Contact Use (21 CFR 601.21 Subpart E) |
| Reproductive Use (Part 21 CFR 601.21 Subpart D) | One-Time Contact Use (21 CFR 601.21 Subpart E) |
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 Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name EasyClip® Xpress
Indications for Use (Describe)
The EasyClip® Xpress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis in adults and pediatrics (children and adolescents).
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 Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
| Proprietary Name: | EasyClip® & EasyClip® Xpress |
|---|---|
| Common Name: | Staple, Fixation, Bone |
| Regulation Description: | Single/multiple component metallic bone fixation appliances and accessories. |
| Regulation Number: | 21 CFR 888.3030 |
| Classification Product Code: | JDR |
| Device Class: | II |
| Sponsor: | Stryker GMBH |
| Bohnackerweg 1 | |
| 2545 Selzach, Switzerland | |
| Contact Person: | Danielle Jannuzzi Madureira, PhD |
| Associate Manager, Regulatory Affairs | |
| Dr. Homer Stryker Strasse, 1 | |
| CH-2545 Selzach, Switzerland | |
| Phone: +41 79 890 02 89 | |
| Fax: +41 32 641 66 60 | |
| Date: | June 10, 2022 |
| Primary Predicate Device: | EasyClip® (Memory Metal Staples) - K122113 |
| Additional Predicate Device: | EasyClip® Xpress - K162321 |
| Device Description: | The EasyClip® & EasyClip® Xpress, previously cleared in K122113 and |
| K162321, includes superelastic bone staples shape memory Nitinol per | |
| ASTM F2063-18. The subject of the bundled submission introduces a | |
| contraindication for both systems and packaging change for EasyClip. | |
| Indications for Use: | The EasyClip® staples are indicated for hand and foot bone |
| fragments osteotomy fixation and joint arthrodesis in adults and | |
| pediatrics (children and adolescents). | |
| The EasyClip® Xpress Staples are indicated for hand and foot bone | |
| fragments osteotomy fixation and joint arthrodesis in adults and | |
| pediatrics (children and adolescents). | |
| Comparison to Predicate | |
| Device: | The intended use of the modified devices, as described in its labeling, has not |
| changed as a result of the modifications proposed in the present submission. | |
| The introduction of a contraindication (EasyClip® and EasyClip® Xpress) | |
| and the packaging change (EasyClip) does not alter the fundamental | |
| scientific technology shared by both the subject devices and predicate | |
| devices. | |
| Performance Data (Nonclinical): | Non-Clinical Performance and Conclusions: |
| Packaging, biocompatibility and corrosion tests were performed according to | |
| ISO 11607-1 and ISO 11607-2, ISO 10993 and ASTM F2129, respectively. |
5
All bench tests performed in accordance with ASTM standards and previously presented in EasyClip® and EasyClip® Xpress. K122113 and K162321, respectively, remains true and accurate.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Conclusion:
The subject devices have the same intended use and similar indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using the equivalent materials and processes as the predicate devices. Except for the modifications described in this submission the subject devices are identical to the predicate devices, and the performance data and analyses demonstrate that:
· any differences do not raise new questions of safety and effectiveness as established with performance testing; and
· the subject devices are substantially equivalent to the legally marketed predicate devices.