(59 days)
Not Found
No
The description focuses on mechanical reaming and fluid management, with no mention of AI/ML terms or functionalities.
No
The device is used to prepare the medullary canal for an implant, which is a surgical tool rather than a therapeutic device.
No
Explanation: The device description states its purpose is to clear and size the medullary canal for an implant, not to diagnose a condition.
No
The device description clearly outlines physical components such as disposable tube assemblies, reamer heads, and reusable drive shafts, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Synthes RIA System Function: The description clearly states the device is used 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." This is a surgical procedure performed directly on the patient's bone, not a test performed on a sample outside the body.
The device is a surgical tool used for preparing the bone during a procedure, not for diagnostic testing of biological samples.
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
Synthes RIA System is a flexible reaming device that consists of a series of disposable tube assemblies, disposable reamer heads and reusable drive shafts. The device is designed for expedited reaming of the medullary canal in preparation for internal fixation. The free-rotating reamer head attaches to the distal end of the tube assembly. Ports in the manifold of the tube assembly allow simultaneous irrigation and aspiration through the tube assembly during the reaming process. Irrigating fluid is passed through the cannula of the drive shaft and reamer head and aspiration is drawn through ports of the retainer and aspiration tube. The RIA device is available in reaming diameters ranging from 10 to 19 mm and effective reaming lengths ranging from 200 to 580 mm.
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.
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).
Special 510(k) Device Modification
§ 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.
0
Summary of Safety and Effectiveness Information: 3.
DEC 21 2001
510(k) SUMMARY
| Submitter: | Synthes (USA)
1690 Russell Road
Paoli, PA 19301 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Bonnie Smith
(610) 647-9700 |
| Name of the Device: | Synthes (USA) Reamer Irrigator Aspirator (RIA) System |
| Classification: | Class II, 21 CFR 888.4540 and 888.1100 |
| Common or Usual Name: | Orthopedic manual surgical instrument; Arthroscope |
| Predicate (unmodified) Device: | Synthes (USA) Reamer Irrigator Aspirator (RIA) System.
K993335 |
| Device Description: | Synthes RIA System is a flexible reaming device that
consists of a series of disposable tube assemblies,
disposable reamer heads and reusable drive shafts. The
device is designed for expedited reaming of the medullary
canal in preparation for internal fixation. The free-rotating
reamer head attaches to the distal end of the tube assembly.
Ports in the manifold of the tube assembly allow
simultaneous irrigation and aspiration through the tube
assembly during the reaming process. Irrigating fluid is
passed through the cannula of the drive shaft and reamer
head and aspiration is drawn through ports of the retainer
and aspiration tube. The RIA device is available in reaming
diameters ranging from 10 to 19 mm and effective reaming
lengths ranging from 200 to 580 mm. |
| 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. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces in profile, suggesting a sense of community and care.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 2002
Ms. Bonnie J. Smith Senior Regulatory Affairs Associate Synthes (USA) P. O. Box 1766 1690 Russell Road Paoli, Pennsylvania 19301
Re: K013527
Trade Name: Synthes Reamer Irrigator Aspirator (RIA) System Regulation Number: 888.4540, 888.1100 Regulation Name: Orthopedic manual surgical instrument Arthroscope and Accessories
Regulatory Class: II Product Code: HTO, HRX Dated: November 29, 2001 Received: November 30, 2001
Dear Ms. Smith:
This letter corrects our substantially equivalent letter of December 21, 2001, regarding the regulation number and product code.
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). 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 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.
2
Page 2 - Ms. Bonnie J. Smith
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.
This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Muriam C. Provost
for 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
3
- Indications for Use
Special 510(k) Device Modification
INTENDED USE STATEMENT
510(k) Number (if known):
Device Name:
Indications
Synthes Reamer Irrigator Aspirator (RIA) System
K013527_______________________________________________________________________________________________________________________________________________________________________
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) | |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.109) | OROver-the-Counter Use |
| (Division Sign-Off) | |
| Division of General, Restorative | |
| and Neurological Devices | |
| Special 510(k): Synthes RIA System | |
| CONFIDENTIAL | |
| 510(k) Number | K013527 |
| 000004 |