(108 days)
Not Found
No
The description focuses on the mechanical components and function of a bone graft delivery system, with no mention of AI or ML.
No
The device is intended for the delivery and pre-mixing of bone graft materials at an orthopedic surgical site, which facilitates a therapeutic procedure but is not itself a therapeutic device that directly treats a condition or disease.
No
The device is intended for the delivery and preparation of bone graft material at a surgical site, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists physical components such as cannulas, syringes, plungers, and caps, indicating it is a hardware device, not software-only.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for the "delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site." It also facilitates mixing bone graft material with various fluids and blood components for delivery to the surgical site. This is a surgical delivery system, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The device components (cannula, syringe, plunger, caps, check valve) are consistent with a system for preparing and delivering materials during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The focus is entirely on the preparation and delivery of bone graft material.
Therefore, the CDO™ System and Graft Preparation System are surgical devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
CDO™ System The CDO™ System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
Graft Preparation System The Graft Preparation System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, plateletrich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
CDO™ System The CDO™ System consists of a curved delivery cannula, a modified syringe, a flexible plunger and an optional syringe adaptor tip.
Graft Preparation System The Graft Preparation System consists of a modified syringe with a check valve, plunger, nozzle cap and end cap.
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)
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
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.
Not Found
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
§ 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
072330
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Image /page/0/Picture/2 description: The image shows the logo for Biomet Biologics, Inc. The logo is in black and white and features the company name in a bold, sans-serif font. The word "BIOMET" is stacked on top of the words "BIOLOGICS, INC." The logo has a simple and modern design.
November 30, 2007
Biomet Biologics, Inc. Applicant/Sponsor:
DEC 0 6 2007
Paula Deming, RN, BSN Contact Person:
Curved Delivery Option (CDO™ System) & Graft Preparation System Proprietary Name:
Common Name: Piston Syringe
Classification Name: FMF (21 CRF 880.5860)
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: CDO™ System
IMBIBE II Syringe (Orthovia, Inc., Malvern, PA) K030208 K022246 Symphony Graft Delivery System (DePuy AcroMed, Raynham, MA)
Graft Preparation System
Graft Delivery System (Biomet Biologics, Inc., Warsaw, IN) K021071
Device Description:
CDO™ System
The CDO™ System consists of a curved delivery cannula, a modified syringe, a flexible plunger and an optional syringe adaptor tip.
Graft Preparation System
The Graft Preparation System consists of a modified syringe with a check valve, plunger, nozzle cap and end cap.
Indications for Use:
CDO™ System
The CDO™ System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
Graft Preparation System
The Graft Preparation System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate premixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
Summary of Technologies: The overall designs, materials and processing methods are similar to the predicate devices to which substantial equivalence is claimed for both the CDO™ and Graft Preparation Systems.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
Biomet® and CDO™ trademarks herein are the property of Biomet, Inc., or its subsidiaries.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.
Public Health Service
DEC 0 6 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomet Biologics, Inc. % Paula Deming Regulatory Specialist PO Box 587 Warsaw, Indiana 46581
Re: K072330
Trade/Device Name: Curved Delivery Option (CDO™) and Graft Preparation System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 30, 2007 Received: December 03, 2007
Dear Ms. Paula Deming:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 – Ms. Paula Deming
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Page 1 of 1
Indications for Use
510(k) Number (if known): K072330
Device Name: Curved Delivery Option (CDO™ System) and Graft Preparation System
Indications For Use:
CDO™ System
The CDO™ System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
Graft Preparation System
The Graft Preparation System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, plateletrich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buell
Division Sign Off
al. Restorative. and Neurological Devices
510(k) Number_KO72330