(51 days)
No
The device description and performance studies focus on a mechanical dispensing system for bone graft material, with no mention of AI or ML capabilities.
No.
The device is a dispensing system for delivering bone graft substitute, which is a therapeutic agent, but the device itself does not directly treat or cure a disease or condition. Its function is mechanical delivery, not therapeutic action.
No
The device is described as a dispensing system for delivering bone graft substitute, and its intended use is to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site. This action (delivery of a substance) is therapeutic, not diagnostic.
No
The device description clearly outlines physical components (dispenser, cannulas) and mentions sterilization and packaging, indicating it is a hardware device for delivering bone graft substitute.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site." This describes a device used in vivo (within the body) for a surgical procedure.
- Device Description: The description details a dispensing system and cannulas for delivering a bone graft substitute. This is consistent with a surgical delivery device, not a device used to test samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely for the delivery of a therapeutic material during surgery.
N/A
Intended Use / Indications for Use
GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.
Product codes
FMF
Device Description
GPS Advanced is a sterile, single use dispensing system for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The instrument system includes 1) a dispenser with a ratcheted plunger that advances with each squeeze of its handle and 2) two 5 cc GPS Advanced Cannulas which can be attached to the dispenser to deliver FIBERGRAFT™ BG Putty GPS.
The 5 cc GPS Advanced Cannula (hereafter referred to as "GPS Advanced Cannula") is also available individually packaged. GPS Advanced and GPS Advanced Cannula are provided sterile via irradiation.
GPS Advanced Cannulas are provided empty and need to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone grafting site
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
The performance data for the subject devices consists of the following evaluations:
- . Biological Risk Assessment
- Sterilization Validation
- . Usability Engineering Evaluation
- . Packaging and Shelf Life Testing, including functional evaluation
Key Metrics
Not Found
Predicate Device(s)
Allograft MIS Delivery System (K201338)
Reference Device(s)
GPS Cannula (Component of FIBERGRAFT™ BG Putty - Bone Graft Substitute, K170306, K222276)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
0
July 10, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Prosidyan, Inc. % Karin Mcdonough Senior Regulatory Affairs Specialist DePuy Synthes 325 Paramount Drive Raynham, Massachusetts 02767
Re: K241426
Trade/Device Name: GPS Advanced; 5 cc GPS Advanced Cannula Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: May 17, 2024 Received: May 20, 2024
Dear Ms. Mcdonough:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely, JESSE MUIR Digitally signed by
JESSE MUIR JESSE MUIR -S Date: 2024.07.10 -5 13:30:25 -04'00' Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K241426
Device Name
GPS Advanced:
5 cc GPS Advanced Cannula
Indications for Use (Describe)
GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.
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)
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4
510(k) Summary
B.
C.
D.
A. Submitter Information
| 510(k) Sponsor: | Prosidyan, Inc.
41 Spring Street #107
New Providence, NJ 07974
USA |
|-------------------------------------------|---------------------------------------------------------------------------------------------------|
| Submitter: | DePuy Synthes
325 Paramount Drive
Raynham, MA 02767
USA |
| Contact Person: | Karin McDonough
Senior Regulatory Affairs Specialist
DePuy Synthes
kmcdono3@its.jnj.com |
| Date Prepared | May 17, 2024 |
| Device Name | |
| Trade/Proprietary Name: | GPS Advanced; 5 cc GPS Advanced Cannula |
| Submission Number | K241426 |
| Common/Usual Name: | Syringe, Piston |
| Device Classification: | Class II |
| Regulation: | 21 CFR §880.5860 - Piston Syringe |
| Classification Product and
Panel Code: | FMF - General Hospital & Personal Use |
| Predicate Device Names | |
| Primary Predicate Device: | Allograft MIS Delivery System (K201338), FMF |
| Reference Device: | GPS Cannula (Component of FIBERGRAFT™ BG Putty - Bone
Graft Substitute, K170306, K222276), FMF |
E. Device Description
GPS Advanced is a sterile, single use dispensing system for the delivery of FIBERGRAFT™ BG Putty GPS bone graft substitute. The instrument system includes 1) a dispenser with a ratcheted plunger that advances with each squeeze of its handle and 2) two 5 cc GPS Advanced Cannulas which can be attached to the dispenser to deliver FIBERGRAFT™ BG Putty GPS.
5
The 5 cc GPS Advanced Cannula (hereafter referred to as "GPS Advanced Cannula") is also available individually packaged. GPS Advanced and GPS Advanced Cannula are provided sterile via irradiation.
GPS Advanced Cannulas are provided empty and need to be filled with FIBERGRAFT™ BG Putty GPS prior to use. FIBERGRAFT™ BG Putty GPS is a bioactive synthetic bone graft substitute in putty format made from 45S5 bioactive glass and has been previously cleared under K170306 (FIBERGRAFT™ BG Putty – Bone Graft Substitute) and K222276 (CONDUIT™ Cages and FIBERGRAFT™ BG Putty). FIBERGRAFT™ BG Putty GPS is not included in the GPS Advanced dispensing system.
F. Indications for Use
GPS Advanced and GPS Advanced Cannula are intended for use to deliver FIBERGRAFT™ BG Putty GPS to a bone grafting site.
G. Summary of Similarities and Differences in Technological Characteristics, Performance, and Intended Use
The technological characteristics, including design, materials, principle of operation and performance as well as intended use of GPS Advanced and GPS Advanced Cannula are consistent with those of the primary predicate and reference device.
H. Performance Data
The performance data for the subject devices consists of the following evaluations:
- . Biological Risk Assessment
- Sterilization Validation
- . Usability Engineering Evaluation
- . Packaging and Shelf Life Testing, including functional evaluation
1. Conclusion
The indications for use of the GPS Advanced and GPS Advanced Cannula are consistent with those of the predicate device. The technological characteristics of the GPS Advanced in terms of design, materials, principle of operation and performance are consistent with those of the predicate devices. GPS Advanced is substantially equivalent to the predicate device.