(175 days)
Not Found
No
The summary describes a mechanical bone staple and associated instrumentation, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device, EasyClip XPress Staples, is indicated for "osteotomy fixation and joint arthrodesis," which are medical treatments aimed at correcting a condition or problem within the body. This falls under the definition of a therapeutic device.
No
Explanation: The device, EasyClip XPress Staples, is a surgical implant (staples) used for osteotomy fixation and joint arthrodesis, which is a therapeutic function, not a diagnostic one. Its purpose is to fix bone fragments, not to identify or assess a medical condition.
No
The device description explicitly states that the device is comprised of "superelastic bone staples, as well as associated instrumentation required for implantation of the staples," indicating it includes 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 is for "hand and foot bone fragments osteotomy fixation and joint arthrodesis." This describes a surgical procedure performed directly on the patient's body to fix bones.
- Device Description: The device is comprised of "superelastic bone staples" and "associated instrumentation required for implantation of the staples." These are physical implants and surgical tools.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The description of the EasyClip XPress Staples does not involve any such testing of samples.
Therefore, the EasyClip XPress Staples are a surgical implant and associated instrumentation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EasyClip XPress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Product codes (comma separated list FDA assigned to the subject device)
JDR
Device Description
EasyClip Xpress is comprised of superelastic bone staples, as well as associated instrumentation required for implantation of the staples.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot bone
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)
Dimensional (geometric cross section) and engineering strength analyses as well as static and dynamic bending tests were conducted initially in K122113 and the results support the conclusion that there are no effects of the modifications subject to this premarket notification on the safety and effectiveness of the EasyClip staples. Other testing performed: Corrosion Testing as per ASTM F2129, Bacterial Endotoxins Test (LAL testing has been performed to establish that the subject device meets the specified 20 EU/device limit).
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
§ 888.3030 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Restore Surgical LLC, dba Instratek Mr. Jeff Seavey President 15200 Middlebrook Drive, Suite G Houston, Texas 77058
February 10, 2017
Re: K162321 Trade/Device Name: 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: January 12, 2017 Received: January 13, 2017
Dear Mr. Seavey:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 006: INDICATIONS FOR USE STATEMENT
510(k) Number: K162321
Device Name: EasyClip Xpress
Indications for Use:
The EasyClip XPress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Restore Surgical LLC, dba Instratek
3
SECTION 007: 510(K) SUMMARY
| Submission Correspondent
and Owner: | Restore Surgical LLC, dba Instratek
15200 Middlebrook Dr., Suite G
Houston, TX 77058
USA
Phone: 281-890-8020
Fax: 281-890-8068
Email: jeff@instratek.com
Contact: Mr. Jeff Seavey
President |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date summary prepared: | August 11, 2016 |
| Device trade name: | EasyClip Xpress |
| Device classification name: | Staple, Fixation, Bone |
| Classification: | Class II |
| Product Code: | JDR |
| Regulation/Description: | 880.3030, Staple, Fixation, Bone |
| Predicate Devices | Stapix Superelastic Nitinol Fixation System (K133523)
Stryker Memory Staple (K122113). |
| Description of the device: | EasyClip Xpress is comprised of superelastic bone staples, as well
as associated instrumentation required for implantation of the
staples. |
| Intended use of the device: | The EasyClip Xpress is indicated for hand and foot bone
fragments osteotomy fixation and joint arthrodesis. |
| Technological
characteristics: | The proposed device has the same design, material, and intended
use as the predicate devices. |
| Testing: | Dimensional (geometric cross section) and engineering strength
analyses as well as static and dynamic bending tests were
conducted initially in K122113 and the results support the conclusion
that there are no effects of the modifications subject to this
premarket notification on the safety and effectiveness of the
EasyClip staples. Other testing performed: Corrosion Testing as per
ASTM F2129, Bacterial Endotoxins Test (LAL testing has been
performed to establish that the subject device meets the
specified 20 EU/device limit). |
| Conclusions: | The results of the comparison of design, materials, intended use and
technological characteristics demonstrate that the device is as safe
and effective as the legally marketed predicate devices. |
Restore Surgical LLC, dba Instratek