(85 days)
No
The 510(k) summary describes a mechanical bone screw and its performance testing, with no mention of AI or ML technology.
Yes
The device is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, all of which are therapeutic interventions.
No
Explanation: The ALLY™ Bone Screws are described as implants used for bone reconstruction, fracture repair, and fixation. They are therapeutic devices, not diagnostic devices which are used to identify a condition or disease.
No
The device description clearly states that the ALLY™ Bone Screws are physical implants manufactured from titanium alloy, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the ALLY™ Bone Screws is for surgical procedures involving bone (reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation). This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a physical implant (bone screw) made of titanium alloy. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- No mention of biological specimens: The description and intended use do not involve the analysis of biological specimens (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Performance Studies: The performance studies described (static torsion, pull out, driving torque, bending strength, bacterial endotoxin) are related to the mechanical and biological safety of the implant, not its ability to diagnose a condition.
In summary, the ALLY™ Bone Screws are a surgical implant used for treatment, not a device used to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
ALLYTM Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Product codes (comma separated list FDA assigned to the subject device)
HWC
Device Description
The ALL Y™ Bone Screws are fully threaded cortical screws offered in various diameters and lengths. All screws are manufactured from titanium alloy. The implants are single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The ALLY™ Bone Screws are evaluated for static torsion, static pull out, and driving torque testing per ASTM F543 Standard Specification and Test Methods for Metallic Bone Screws.
Engineering analysis for screw bending strength has been completed.
Bacterial Endotoxin testing (LAL) has been completed and shown to meet the device limits.
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.
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
§ 888.3040 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or a sense of movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Providence Medical Technology, Inc. Edward Liou Chief Operating Officer 1331 N. California Blvd., Suite 320 Walnut Creek, California 94596
May 31, 2017
Re: K170698
Trade/Device Name: ALLYTM Bone Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: May 17, 2017 Received: May 18, 2017
Dear Mr. Liou:
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 of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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/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
2
Indications for Use Statement
510(k) Number (if known):_K170698
Device Name: ALLY™ Bone Screws
Indications for Use:
ALLY™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.
Prescription Use ___ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) SUMMARY
Providence Medical Technology's ALLYTM Bone Screws
| Date Prepared: | May 26, 2017 |
|---|---|
| Company: | Providence Medical Technology, Inc. |
| 1331 N. California Blvd., Suite 320 | |
| Walnut Creek, CA 94596 | |
| Contact Person: | Edward Liou |
| ed@providencemt.com | |
| Phone: 415-923-9376 | |
| Fax: 415-923-9377 | |
| Trade Name: | ALLY™ Bone Screws |
| Common Name: | Bone screw |
| Classification Name: | Screw, fixation, bone |
| Regulation Number: | 21 CFR Part 880.3040 |
| Product Code: | |
| Class: | HWC |
| Class II | |
| Predicate Devices: | |
| Primary Predicate: | PMT Bone Screws (K121713, cleared 09/27/2012) |
| Reference Devices: | Orthohelix Surgical Designs, Inc.: CSS Cannulated Screw System |
| (K060428, cleared 03/07/2006) |
(K082320, cleared 11/05/2008)
Device Description
The ALL Y™ Bone Screws are fully threaded cortical screws offered in various diameters and lengths. All screws are manufactured from titanium alloy. The implants are single use only.
Indications for Use
The ALLY™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device.
Wright Medical Technology, Inc.: WRIGHT™ Compression Screws
4
Technological Characteristics
The ALLYTM Bone Screws have the following technological characteristics:
- o Manufactured from Titanium Alloy
- o Available headed, headless, or snap-off with various tip configurations
- 0 Available in various diameters and lengths
Performance Data
The ALLY™ Bone Screws are evaluated for static torsion, static pull out, and driving torque testing per ASTM F543 Standard Specification and Test Methods for Metallic Bone Screws.
Engineering analysis for screw bending strength has been completed.
Bacterial Endotoxin testing (LAL) has been completed and shown to meet the device limits.
Substantial Equivalence
The ALLY™ Bone Screws are as safe and effective as the predicate device. The ALLY™ Bone Screws have the same indications for use, technological characteristics, and principles of operation as its predicate device. The reference devices are available in the extended size ranges being added to the ALLYTM Bone Screws.
Comparison between ALLY™ Bone Screws and its predicate devices raises no new issues of safety or effectiveness. The ALLY™ Bone Screws are substantially equivalent to the PMT Bone Screws.