(33 days)
The Arthrex Mixing and Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
The Arthrex Mixing and Delivery System consists of a piston syringe with a movable plunger and cap to facilitate mixing and delivery; straight and curved (tuohy) delivery needles; a mating obturator for delivery needles; luer connectors; and a funnel to facilitate filling of the syringe barrel. The system will be offered with either a 3mL or 14 mL syringe barrel and may be provided either empty or pre-filled with allograft, autograft, or synthetic bone graft materials.
The provided text describes a 510(k) submission for the Arthrex Mixing and Delivery System, a medical device. However, it does not contain information on explicit acceptance criteria for device performance, nor does it detail a study proving the device meets such criteria.
The submission focuses on establishing substantial equivalence to predicate devices based on intended use, basic features, biocompatibility, and mechanical testing. The key sections missing to answer your request are:
- Specific performance metrics: What quantitative or qualitative measures are used to define the device's performance? (e.g., flow rate, mixing homogeneity, delivery force, material integrity after mixing).
- Acceptance thresholds: What are the pass/fail criteria for these performance metrics? (e.g., "flow rate must be within X +/- Y mL/s," "no material degradation observable").
- Detailed study design: A description of how a study was conducted to evaluate these metrics against the acceptance criteria.
Based on the available information, here is what can be inferred and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
No explicit acceptance criteria or reported device performance metrics are provided in the document. The document states that "Based on the biocompatibility and mechanical testing performed, Arthrex, Inc. has determined that the Arthrex Mixing and Delivery System is substantially equivalent to the marketed predicate devices." This implies that the device met some internal or industry-standard criteria related to these aspects, but the specifics are not disclosed.
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|
| (Performance criteria for mixing efficacy, delivery force, material integrity, etc., would typically be listed here.) | (Specific results from mechanical and biocompatibility testing that demonstrate adherence to acceptance criteria would be listed here.) |
| Biocompatibility standards met (Implicit) | Biocompatibility testing performed and deemed equivalent to predicates (Implicit) |
| Mechanical performance similar to predicates (Implicit) | Mechanical testing performed and deemed equivalent to predicates (Implicit) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document mentions "mechanical testing performed" and "biocompatibility," but does not provide details on the number of units tested.
- Data Provenance: Not specified, but likely from testing conducted by Arthrex, Inc. No mention of geographical origin (country) or retrospective/prospective nature of data as this is a device submission for a physical product, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable as this is not a study involving human-established ground truth for diagnostic or interpretative tasks. Evaluation would be based on engineering and materials science principles.
4. Adjudication Method for the Test Set
- Not applicable for a device performance evaluation of this nature.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/software device and does not involve human readers interpreting data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device.
7. The Type of Ground Truth Used
- For biocompatibility: Likely established through regulatory standards (e.g., ISO 10993 series) and in vitro or in vivo testing where the "ground truth" is adherence to established biological safety limits.
- For mechanical testing: Likely established through engineering specifications, material properties standards, and direct measurement against defined functional requirements (e.g., piston movement, luer connection integrity, material flow through needles).
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this device.
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Arthrex TRADITIONAL 510(k): Arthrex Mixing and Delivery System
3 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | April 11, 2012 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA |
| 510(k) Contact | Christina FloresRegulatory Affairs SpecialistArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1819Fax: 239/598.5508Email: Christina.flores@arthrex.com |
| Trade Name | Arthrex Mixing and Delivery System |
| Common Name | Piston Syringe |
| Product Code -ClassificationNameCFR | Syringe, PistonFMF21 CFR 880.5860 |
| Predicate Device | K062986 Medtronic Graft Delivery SyringeK012738, DePuy Symphony Graft Delivery SystemK062365 Arthrex Aspirate Kit |
| Purpose of Submission | This Traditional 510(k) premarket notification issubmitted to obtain clearance for the Arthrex Mixing andDelivery System. |
| Device Description and IntendedUse | The Arthrex Mixing and Delivery System consists of apiston syringe with a movable plunger and cap to facilitatemixing and delivery; straight and curved (tuohy) deliveryneedles; a mating obturator for delivery needles; luerconnectors; and a funnel to facilitate filling of the syringebarrel. The system will be offered with either a 3mL or 14mL syringe barrel and may be provided either empty orpre-filled with allograft, autograft, or synthetic bone graftmaterials.The Arthrex Mixing and Delivery System, like thepredicates, is intended to provide the surgeons with ameans to mix and deliver graft material to an orthopedicsurgical site. |
| Arthrex Mixing and Delivery System is indicated for thedelivery of allograft, autograft, or synthetic bone graftmaterials to all orthopedic surgical sites. In addition, it isdesigned to facilitate pre-mixing of allograft, autograft, orsynthetic bone graft materials with I.V. fluids, blood,plasma, platelet rich plasma, bone marrow or other specificblood component(s) as deemed necessary by the clinicaluse requirements. | |
| Substantial EquivalenceSummary | The Arthrex Mixing and Delivery System is substantiallyequivalent to the predicate devices, in which the basicfeatures and intended uses are the same. Any differencesbetween the Arthrex Mixing and Delivery System and thepredicates are considered minor and do not raise questionsconcerning safety and effectiveness.Based on the biocompatibility and mechanical testingperformed, Arthrex, Inc. has determined that the ArthrexMixing and Delivery System is substantially equivalent to the marketed predicate devices. |
Arthrex Inc. • 1370 Creekside Boulevard • Naples, Florida 34108-1945 USA • - Arthrex Hier - 1970 - 210cables - Fax: 239-430-3490 • website: www.arthrex.com
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Arthrex TRADITIONAL 510(k): Arthrex Mixing and Delivery System
Arthrex Inc. • 1370 Creekside Boulevard • Naples, Florida 34108-1945 USA • Tel: 800-933-7001 or 239-643-5553 • Fax: 239-430-3490 • website: www.arthrex.com
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Incorporated % Ms. Christina Flores Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
MAY 1 6 2012
Re: K121124
Trade/Device Name: Arthrex Mixing and Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: May 7, 2012 Received: May 8, 2012
Dear Ms. Flores:
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 device-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.
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Page 2 - Ms. Christina Flores
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark N. Melkerson Director .
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Arthrex TRADITIONAL 510(k): Arthrex Mixing and Delivery System
2 Indications for Use Form
510(k) Number:
Device Name:
Arthrex Mixing and Delivery System
The Arthrex Mixing and Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
Prescription Use_X_AND/OR Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
l of 1
Neil R. Orden for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121124
Arthrex Inc. • 1370 Creekside Boulevard • Naples, Florida 34108-1945 USA • Tel: 800-933-7001 or 239-643-5553 • Fax: 239-430-3490 • website: www.arthrex.com
5
§ 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).