(77 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterility of a physical implant (facet screws), with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
Explanation: The device is indicated for posterior surgical treatment of various spinal conditions (trauma, spondylolisthesis, pseudoarthrosis, degenerative diseases) and provides temporary stabilization as an adjunct to spinal fusion, fitting the definition of a therapeutic device.
No
Explanation: The device is described as an implantable screw for spinal fusion, providing mechanical support and stability. It is used in treatment, not for diagnosing medical conditions. Diagnosis is mentioned as being confirmed by patient history and radiographs, but the device itself does not perform the diagnostic function.
No
The device description explicitly states it is a permanent implant device manufactured from Titanium-6AL-4V ELI, which is a hardware component. The performance studies also focus on mechanical testing of the physical screws.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description: The ALLY™ Facet Screws are described as "permanent implant devices" intended for "posterior surgical treatment" and providing "mechanical support and stability." This clearly indicates they are implanted within the body (in vivo) and are not used for testing biological samples.
- Intended Use: The intended use describes surgical procedures and the treatment of spinal conditions, not diagnostic testing.
Therefore, based on the provided information, the ALLY™ Facet Screws are a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
-
Trauma, including spinal fractures and/or dislocations;
-
Spondylolisthesis;
-
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity: and
-
Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radios and/ or (b) degenerative disease of the facets with instability.
The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.
Product codes
MRW
Device Description
The ALLY™ Facet Screws are permanent implant devices manufactured from Titanium-6AL-4V ELI. The device is available in a variety of diameters and lengths to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The device is supplied sterile and single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2 to S1 (inclusive) spinal levels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
posterior surgical treatment
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
The following testing was performed using the subject device and results were compared to those of the predicate device:
- Static and Dynamic Cantilever Bending
- ASTM F2193-14 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
- Static Torsion Testing
- ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws
- Static Pull-Out Testing
- ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws
- Drive Torque
- ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws
In addition, the following testing was performed:
- Pyrogenicity Testing
- Pyrogenicity Testing was conducted in compliance with the FDA Guidance Documents listed below:
- "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff"
- "Pyrogen and Endotoxins Testing: Questions and Answers"
- Bacterial endotoxin testing (BET) as specified in USP is used for pyrogenicity testing to achieve the Endotoxin limit of
- Pyrogenicity Testing was conducted in compliance with the FDA Guidance Documents listed below:
N/A
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 two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The abstract symbol is a stylized representation of a human figure, composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2017
Providence Medical Technology, Inc. Mr. Edward Liou Chief Operating Officer 1331 North California Boulevard, Suite 320 Walnut Creek, California 94596
Re: K163374
Trade/Device Name: ALLYTM Facet Screws Regulatory Class: Unclassified Product Code: MRW Dated: January 17, 2017 Received: January 19, 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 (reporting of medical devicerelated 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.
1
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
510(k) Number (if known) K163374
Device Name ALLY™ Facet Screws
Indications for Use (Describe)
The ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
-
Trauma, including spinal fractures and/or dislocations;
-
Spondylolisthesis;
-
Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity: and
-
Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radios and/ or (b) degenerative disease of the facets with instability.
The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
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3
510(k) SUMMARY
Providence Medical Technology, Inc.'s ALLY™ Facet Screws
| Date Prepared: | February 8, 2017 |
|---|---|
| Company: | Providence Medical Technology, Inc. |
| 1331 N. California Blvd., Suite 320 | |
| Walnut Creek, CA 94596 | |
| Contact Person: | Edward Liou |
| Phone: 415.923.9376 | |
| Facsimile: 415.923.9377 | |
| Trade Name: | ALLY™ Facet Screws |
| Common Name: | Facet screw |
| Classification | |
| Name: | System, Facet Screw Spinal Device |
| Product Code, | |
| Class: | MRW, Unclassified |
| Predicate Devices: | |
| Primary Predicate: SpartanS3 Facet System (K092568, cleared 11/17/09) | |
| (This device has not been subject to recall.) | |
| Additional Predicates: | Venus Facet Screw System (K120340, cleared 10/19/12) |
| Facet Fixx (K131417, cleared 7/12/13) |
Indications for Use:
The ALLY™ Facet Screws are indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels:
-
- Trauma, including spinal fractures and/or dislocations;
-
- Spondylolisthesis;
-
- Pseudoarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity;
-
- Degenerative diseases which include: (a) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient
4
history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.
The ALLY™ Facet Screws provide temporary stabilization as an adjunct to spinal fusion.
Device Description
The ALLY™ Facet Screws are permanent implant devices manufactured from Titanium-6AL-4V ELI. The device is available in a variety of diameters and lengths to accommodate patient anatomy. The device is intended to provide mechanical support and stability to the implanted level until biologic fusion is achieved. The device is supplied sterile and single-use only.
Technological Characteristics.
The ALLY™ Facet Screws have technical characteristics similar to the predicate devices. See table below for a comparison of technical attributes.
| Technological Characteristics | |
|---|---|
| ALLY™ Facet Screws | |
| (Subject Device) | Spartan S³ Facet System |
| (Predicate Device) | |
| Single use only implant | Same |
| Supplied sterile, individually packaged | Same |
| Implant material is 6Al-4V Titanium conforming to | |
| ASTM F136 | Same |
| Fully threaded and lag versions | Same |
| Self-drilling and self-tapping | Same |
Performance Testing
The following testing was performed using the subject device and results were compared to those of the predicate device:
Static and Dynamic Cantilever Bending
- ASTM F2193-14 Standard Specifications and Test Methods for Components ● Used in the Surgical Fixation of the Spinal Skeletal System
Static Torsion Testing
5
- ASTM F543-13 Standard Specification and Test Methods for Metallic Medical ● Bone Screws
Static Pull-Out Testing
- · ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws
Drive Torque
ASTM F543-13 Standard Specification and Test Methods for Metallic Medical Bone Screws
In addition, the following testing was performed:
Pyrogenicity Testing
- · Pyrogenicity Testing was conducted in compliance with the FDA Guidance Documents listed below:
- "Submission and Review of Sterility Information in Premarket O Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff"
- "Pyrogen and Endotoxins Testing: Questions and Answers" O
- Bacterial endotoxin testing (BET) as specified in USP is used for o pyrogenicity testing to achieve the Endotoxin limit of