(29 days)
No
The description focuses on mechanical components and material properties, with no mention of AI, ML, or data processing capabilities.
No.
The device is described as a "graft preparation and delivery device" intended for the delivery and premixing of bone graft materials, but it does not itself directly provide therapeutic action. Its purpose is to prepare and deliver materials that might then contribute to therapeutic outcomes.
No
The device is intended for the delivery of bone graft material and its preparation, not for diagnosing a condition or disease.
No
The device description explicitly details physical components made of materials like ABS, polycarbonate, polypropylene, silicone, and stainless steel, and describes physical testing like plunger force and stylet buckling, indicating it is a hardware device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for the "delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site." It also facilitates the "premixing of bone graft materials with fluids." This describes a device used during a surgical procedure to prepare and deliver materials directly to a patient's body.
- Device Description: The description details the physical components of a delivery system (syringe body, plunger, cannula, etc.) and the materials used. This aligns with a surgical instrument or delivery device, not a diagnostic test.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) to diagnose a condition, monitor a disease, or determine compatibility. The fluids mentioned are for hydrating the graft material, not for diagnostic testing.
- Performance Studies: The performance studies focus on the mechanical integrity, biocompatibility, and functionality of the device for delivery and preparation, not on the accuracy or reliability of a diagnostic test.
In summary, the device's purpose is to facilitate the delivery of bone graft material during surgery, which is a therapeutic or procedural function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
Product codes
FMF
Device Description
The Graft Delivery Device with Integrated Stylet is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
The Graft Delivery Device with Integrated Stylet consists of a syringe body, plunger with integrated stylet, tapered end cap, funnel, cap plug, and cannula. Hydration components (hydration tube or hydration adapter) are present in some configurations. Components are made of one or more of the following materials: acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, self-lubricating silicone, and 304 Stainless Steel.
The device is packaged in a thermoformed tray with a Tyvek Iid. Each tray is then packaged in a labeled individual poly/Tyvek pouch. Five (5) pouched trays are then put into a shelf box and then a cardboard shipper box. Like the graft delivery device from K100754, the Graft Delivery Device with Integrated Stylet is sterilized using ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orthopedic surgical 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Graft Delivery Device with Integrated Stylet was evaluated through design verification and biocompatibility testing. Biocompatibility testing performed in accordance with ISO 10993 -Biological evaluation of medical devices, Part 1 – Evaluation and tests (2009) show the device is considered safe for use for its intended biocontact. Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use and over the labeled shelf life.
Testing was conducted for the following:
- Plunger Force
- Stylet Force
- Closed System Leak
- Vented System
- Secondary Thumb Tab Force
- Cannula Atraumatic Tip
- Dimensional Testing
- Cap Plug/Tapered End Cap/Syringe Finger Flange Strength
- Plunger Thumb Pad Strength
- Cannula/Tapered End Cap Strength
- Hydration Adapter/Tapered End Cap Strength
- Hydration Tube/Tapered End Cap Strength
- Stylet Torque
- Stylet Buckling
- Hydration Tube Strength
- Sterilization
- Shelf life
- Packaging
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2015
Micromedics Incorporated Ms. Amy L. Peterson Senior Regulatory Affairs Specialist 1270 Eagan Industrial Road, Suite 120 Saint Paul, Minnesota 55121
Re: K151543
Trade/Device Name: Graft Delivery Device with Integrated Stylet Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: June 4, 2015 Received: June 8, 2015
Dear Ms. Peterson:
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
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/ResourcesforYou/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.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151543
Device Name
Graft Delivery Device with Integrated Stylet
Indications for Use (Describe)
The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Date of Summary Preparation: July 3, 2015
510(k) Applicant/Submitter Micromedics, Inc. d/b/a Nordson Medical 1270 Eagan Industrial Road St. Paul, MN 55121-1385 Tel: 651-452-1977; Fax: 651-452-1787 Establishment Registration #2183425
Contact Person Amy L. Peterson, M.A. Sr. Regulatory Affairs Specialist Micromedics, Inc. d/b/a Nordson Medical 1270 Eagan Industrial Road St. Paul, MN 55121-1385 Tel: 651-405-2182; Fax: 651-452-1787
| General Information | |||
|---|---|---|---|
| Trade Name | Graft Delivery Device with | ||
| Integrated Stylet | Common Name | Graft Delivery Device | |
| Classification | |||
| Information | Syringe, Piston | ||
| per 21 CFR 880.5860 (Class II) | Product Code | FMF | |
| Panel | General Hospital | ||
| Predicate | |||
| Devices | Micromedics Inc's Graft Delivery System, K100754, cleared June 9, 2010 | ||
| Biomet Biologics' CDO™ and Graft Preparation System, K072330, cleared | |||
| December 6, 2007 |
Device Description
The Graft Delivery Device with Integrated Stylet is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
The Graft Delivery Device with Integrated Stylet consists of a syringe body, plunger with integrated stylet, tapered end cap, funnel, cap plug, and cannula. Hydration components (hydration tube or hydration adapter) are present in some configurations. Components are made of one or more of the following materials: acrylonitrile butadiene styrene (ABS), polycarbonate, polypropylene, self-lubricating silicone, and 304 Stainless Steel.
The device is packaged in a thermoformed tray with a Tyvek Iid. Each tray is then packaged in a labeled individual poly/Tyvek pouch. Five (5) pouched trays are then put into a shelf box and then a cardboard shipper box. Like the graft delivery device from K100754, the Graft Delivery Device with Integrated Stylet is sterilized using ethylene oxide.
4
Intended Use / Indications
The graft preparation and delivery device is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as IV fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.
Substantial Equivalence Comparison
The Graft Delivery Device with Integrated Stylet is substantially equivalent to the predicate devices in the following characteristics:
- Operational mode
- Basic Scientific Technology .
- . Intended Use
- General physical characteristics .
Summary of Non-Clinical Performance Data
The Graft Delivery Device with Integrated Stylet was evaluated through design verification and biocompatibility testing. Biocompatibility testing performed in accordance with ISO 10993 -Biological evaluation of medical devices, Part 1 – Evaluation and tests (2009) show the device is considered safe for use for its intended biocontact. Non-clinical testing included the tests listed below and showed the test articles met the pre-defined acceptance criteria, therefore demonstrating the mechanical integrity and suitability of the device for its intended use and over the labeled shelf life.
Testing was conducted for the following:
- Plunger Force ●
- Stylet Force ●
- Closed System Leak ●
- Vented System
- Secondary Thumb Tab Force
- Cannula Atraumatic Tip ●
- Dimensional Testing ●
- Cap Plug/Tapered End Cap/Syringe Finger Flange Strength
- . Plunger Thumb Pad Strength
- Cannula/Tapered End Cap Strength ●
- . Hydration Adapter/Tapered End Cap Strength
- Hydration Tube/Tapered End Cap Strength ●
- Stylet Torque ●
- . Stylet Buckling
- Hydration Tube Strength ●
- Sterilization ●
- Shelf life ●
- Packaging .
- Summary of Clinical Performance Data
None provided as a basis for substantial equivalence.
Substantial Equivalence Conclusion
As evidenced by the successful completion of non-clinical performance testing, the Graft Delivery Device with Integrated Stylet does not raise new questions of safety or effectiveness when compared to the predicate devices and is, therefore, substantially equivalent.