(252 days)
N/A
No
The description focuses on mechanical components for reaming and irrigation/aspiration, with no mention of AI/ML terms or functions.
No
The device is used to clear and size the medullary canal for an implant, which is a preparatory step for treatment, not the treatment itself.
No
Explanation: The device is described as a surgical reaming system used to clear and size the medullary canal for an implant. It is an operative device, not one that provides diagnostic information.
No
The device description explicitly details physical components like disposable reamer assemblies, reusable drive shafts, a reamer head, manifold/tube assembly, and mentions irrigation and aspiration, indicating it is a hardware-based medical device.
Based on the provided information, the Synthes RIA System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for clearing the medullary canal of bone marrow and debris and sizing it for an implant. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a mechanical device with reamer assemblies and drive shafts used for physical manipulation within the bone. It involves irrigation and aspiration during a surgical process.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, tissue, urine, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. The Synthes RIA System is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis.
Product codes (comma separated list FDA assigned to the subject device)
HTO, HRX
Device Description
The RIA System consists of two types of components; a series of disposable reamer assemblies and reusable drive shafts. The RIA is a device designed for expedited reaming of a medullary canal in preparation of internal fixation. The device includes a free rotating reamer head connected to the distal end of the manifold/tube assembly. The manifold allows both irrigation and aspiration during the reaming process. Irrigation is passed through the cannulation of the reamer and aspiration is drawn from the rear of the flutes in the reamer. The RIA coupled with the Drive Shaft serves as a flexible reaming device and is available in reaming diameters ranging from 9 mm to 24 mm and range in 200 mm to 550 mm in effective reaming lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
medullary canal
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)
Not Found
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.
Synthes Inramedullary Reamers, Zimmer's Flexible Intramedullary Reamer, Davol's Pneumatic Arthroscopy Pulsed Irrigator System
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
§ 888.4540 Orthopedic manual surgical instrument.
(a)
Identification. An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
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JUN 1 2 2000
Image /page/0/Picture/2 description: The image shows a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the digits '993335'. The digits are written in a simple, slightly irregular style.
| Attachment VIII: | Summary of Safety and Effectiveness [510(k) Summary] |
|---|---|
| SUBMITTER | Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 |
| Contact: Sheri L. Musgnung | |
| DEVICE NAME: | Synthes Reamer/Irrigator/Aspirator (RIA) System |
| COMMON OR USUAL NAME | Jet lavage; Vacuum-powered body fluid suction apparatus; Arthroscope |
| DEVICE CLASSIFICATION: | Class II, 21 CFR 880.5475; 880.6740; and 888.1100 |
| PREDICATE DEVICE: | Synthes Inramedullary Reamers Zimmer's Flexible Intramedullary Reamer Davol's Pneumatic Arthroscopy Pulsed Irrigator System |
| DESCRIPTION: | The RIA System consists of two types of components; a series of disposable reamer assemblies and reusable drive shafts. The RIA is a device designed for expedited reaming of a medullary canal in preparation of internal fixation. The device includes a free rotating reamer head connected to the distal end of the manifold/tube assembly. The manifold allows both irrigation and aspiration during the reaming process. Irrigation is passed through the cannulation of the reamer and aspiration is drawn from the rear of the flutes in the reamer. The RIA coupled with the Drive Shaft serves as a flexible reaming device and is available in reaming diameters ranging from 9 mm to 24 mm and range in 200 mm to 550 mm in effective reaming lengths. |
| INTENDED USE: | Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis |
CONFIDENTIAL
prosthesis.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2000
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road P.O. Box 1766 Paoli. Pennsylvania 19301
K993335 Re:
Trade Name: Synthes Reamer/IrrigatorAspirator (RIA) System Regulatory Class: II Product Code: HTO, HRX Dated: May 1. 2000 Received: May 2, 2000
Dear Ms. Musgnung:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Dana R. Lochner -
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative
and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 2.0
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
510(k) Number (if known):
Synthes Reamer/Irrigator/Aspirator (RIA) System Device Name:
(99333)
Indications For Use:
Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
S Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Danne R. Vachner.
(Division Sign-Off) (Division Sign-On)
Division of General Restorative Devices 943335 510(k) Number ڪلا
Synthes (USA) Reamer/Irrigator/Aspirator (RIA) System CONFIDENTIAL
000004