(57 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implant and surgical instruments, with no mention of AI or ML.
No.
The device is an implantable bone anchor used to attach soft tissue to bone during rotator cuff repair. While it aids in the healing process, it does not directly act as a therapeutic agent or deliver therapy itself. Its primary function is mechanical fixation.
No
The device is an implantable bone anchor used for surgical repair of rotator cuff tears, which focuses on fixation rather than diagnosis.
No
The device description clearly states that the Elite SPK is an implantable bone anchor made of PEEK and the Compasso is a series of manual surgical instruments made of stainless steel and other materials. These are physical hardware components, not software.
Based on the provided information, the Elite SPK device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears." This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details an "implantable bone anchor device" made of PEEK, designed for fixing soft tissues to bone. This is a physical implant used in surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. The Elite SPK is an implantable device used inside the body during surgery.
N/A
Intended Use / Indications for Use
The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. It is intended to be implanted using the Compasso surgical instruments.
Compasso is a series of surgical instruments intended for use for the Elite SPK or the Sharc-FT bone anchor.
Product codes
MBI
Device Description
The Elite SPK is an implantable bone anchor device designed to ensure the fixation of soft tissues (especially tendons) to bone, during the repair of injuries to the shoulder performed with open or arthroscopic technique. The implantable anchor is made of polyether ether ketone (PEEK), and allows the surgeon to attach the injured tendon to the humerus using a transosseous "double row" technique. The ELITE SPK anchor is suitable for a 3 mm in diameter hole, and is provided sterile for single use.
The Compasso is a series of manual surgical instruments to implant the Elite SPK. Instruments in contact with human body are made of Stainless Steel in conformity with ISO 5832-1, while other components not in contact with the patient are made of stainless steel, aluminum and laser sintering polyamide.
The Elite SPK may be provided in a kit form with sutures for physician convenience. The sutures are provided in their final, sterile form in the original packaging from the manufacturer. FDA has previously cleared the provided sutures in 510(k) application K100006; specifically, the kit includes the HS Fiber Sutures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue to bone during arthroscopic or open treatment of rotator cuff tears (shoulder/humerus)
Indicated Patient Age Range
adults
Intended User / Care Setting
orthopedic surgeons
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
Sterilization and Shelf Life: The devices are sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices has been established through stability studies.
Biocompatibility: Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" have been taken into account to evaluate the biocompatibility of the device materials.
Performance Testing: Performance testing was performed to evaluate the fixation strength of the Elite SPK compared to the predicate device. These tests showed that the Elite SPK has adequate fixation strength and is comparable to the predicate devices.
The performance data demonstrate that the Elite SPK and Compasso are substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted 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 is a circular seal with the words "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
April 20, 2016
NCS Lab Srl % Christine Brauer. Ph.D. Regulatory Affairs Consultant Brauer Device Consultants, LLC 7 Trail House Court Rockville, Maryland 20850
Re: K160500
Trade/Device Name: Elite SPK. Compasso. Elite SPK Kit Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: February 22, 2016 Received: February 23, 2016
Dear Dr. Brauer:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160500
Device Name Elite SPK, Elite SPK Kit and Compasso
Indications for Use (Describe)
The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. It is intended to be implanted using the Compasso surgical instruments.
Compasso is a series of surgical instruments intended for use for the Elite SPK or the Sharc-FT bone anchor.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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:
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
1 GENERAL INFORMATION
Submitter and Owner of the 510(k) Application 1.1
NCS Lab Srl Via Pola Esterna 4/12 Carpi (MO), Italy 41012
1.2 Official Correspondent
Christine L. Brauer, PhD Regulatory Affairs Consultant Brauer Device Consultants, LLC 7 Trail House Court Rockville, MD 20850
Telephone: (301) 545-1990 Fax: (301) 545-1992 E-mail: chris.brauer(@comcast.net
Devices Subject of this 510(k) 1.3
Elite SPK Compasso Elite SPK Kit
Date of Preparation 1.4
April 18, 2016
2 NAME OF THE DEVICE AND CLASSIFICATION INFORMATION
Trade/Proprietary Name 2.1
This 510(k) application is for the following devices:
- Elite SPK, a sterile, single-use implantable suture anchor;
- . Compasso, a series of reusable surgical instruments used to implant the Elite SPK; and,
- . Elite SPK Kit, a sterile, single-use implantable suture anchor and sutures.
2.2 Common/Usual Name
Bone Anchor
Orthopedic Manual Surgical Instruments to Implant the Bone Anchor
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2.3 Classification Information
| Classification Name: | Smooth or Threaded Metallic Bone Fixation Fastener |
|---|---|
| Classification Regulation: | 888.3040 |
| Regulatory Class: | II |
| Product Code: | MBI – Fastener, Fixation, Nondegradable, Soft Tissue |
| Panel: | Orthopedic |
3 PREDICATE DEVICE
The predicate device is as follows:
-
. NCS Lab Srl's NCS Sharc FT System, which was cleared through 510(k) application K120356.
The following reference device was considered in analysis of the technological characteristics of the device materials and certain design aspects. -
. Reference device for discussion of device materials and partially threaded design: Quattro Link Knotless Anchors, manufactured by Cayenne Medical, and cleared via K122314
The Elite SPK may be provided in a kit form with sutures. The sutures have previously received clearance from FDA (Riverpoint Medical Force Fiber, K100006), and are provided in their final, sterilized form to NCS Lab Srl.
DEVICE DESCRIPTION 4
The Elite SPK is an implantable bone anchor device designed to ensure the fixation of soft tissues (especially tendons) to bone, during the repair of injuries to the shoulder performed with open or arthroscopic technique. The implantable anchor is made of polyether ether ketone (PEEK), and allows the surgeon to attach the injured tendon to the humerus using a transosseous "double row" technique. The ELITE SPK anchor is suitable for a 3 mm in diameter hole, and is provided sterile for single use.
The Compasso is a series of manual surgical instruments to implant the Elite SPK. Instruments in contact with human body are made of Stainless Steel in conformity with ISO 5832-1, while other components not in contact with the patient are made of stainless steel, aluminum and laser sintering polyamide.
1 The tradename of the device was changed from the NCS Fish-Fit MD System to the NCS Sharc FT System after clearance.
5
The Elite SPK may be provided in a kit form with sutures for physician convenience. The sutures are provided in their final, sterile form in the original packaging from the manufacturer. FDA has previously cleared the provided sutures in 510(k) application K100006; specifically, the kit includes the HS Fiber Sutures.
ഗ INDICATION FOR USE
The indication for use statement is provided below.
The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. It is intended to be implanted using the Compasso surgical instruments.
Compasso is a series of surgical instruments intended for use for the implantation of the Elite SPK or the Sharc-FT bone anchor.
COMPARISON OF THE INTENDED USE WITH THE PREDICATE DEVICE 6
The Elite SPK and the predicate device share the same intended use. Both devices are intended for use during arthroscopic or open surgeries to repair rotator cuff injuries. Both devices serve the same primary function: namely, to secure the tendons to the bone during healing. Both devices are used by the same health care professionals (orthopedic surgeons) in the same target patient population: adults who require surgical repair of rotator cuff injuries. Both devices are implanted into a cavity drilled into the bone, are implanted using the same surgical instruments and remain implanted in the bone.
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE 7 PREDICATE DEVICE
The Elite SPK and the predicate share certain technological features, but also have some differences. The primary difference between the Elite SPK and the Sharc FT are in materials and design. The Elite SPK is made from polyether ether ketone (PEEK) whereas the Sharc FT is made of titanium. The Elite SPK incorporates a screw type design with a wider contact head and partially threaded (referred to as side flaps or wings), whereas the Sharc FT consists of a deformable U-shape body design. Both devices have heads with eyelets to pass sutures.
Other bone anchors are made from PEEK and are available in a variety of designs included "threaded" (either full or partially) or "smooth" screw-shape designs. One such bone anchor, the, Quattro Link Knotless Anchors, manufactured by Cayenne Medical, and cleared via K 122314, is cited here as a reference predicate device for materials and general design shape.
8 PERFORMANCE DATA
This 510(k) submission provided performance data to establish the substantial equivalence of the Elite SPK and Compasso to the predicate devices. The following is a summary of the performance data.
6
Sterilization and Shelf Life: The devices are sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices has been established through stability studies.
Biocompatibility: Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" have been taken into account to evaluate the biocompatibility of the device materials.
Performance Testing: Performance testing was performed to evaluate the fixation strength of the Elite SPK compared to the predicate device. These tests showed that the Elite SPK has adequate fixation strength and is comparable to the predicate devices.
The performance data demonstrate that the Elite SPK and Compasso are substantially equivalent to the predicate devices.