(147 days)
No
The description focuses on mechanical reaming and bone harvesting, with no mention of AI/ML terms or functionalities.
Yes
The device is described as clearing and sizing the medullary canal for an implant/prosthesis, and harvesting bone/marrow for bone graft, which are therapeutic interventions.
No
The device description indicates its purpose is to clear the medullary canal, size it for implants, and harvest bone/bone marrow. These are all procedural functions, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including disposable tube assemblies, disposable reamer heads, tube assemblies, drive shaft seals, and reusable drive shafts.
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 describes a surgical device used for preparing the medullary canal and harvesting bone and bone marrow within the body. This is an in vivo procedure.
- Device Description: The description details a mechanical reaming and aspiration system used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens outside the body (in vitro) to provide information about a physiological state, health, or disease.
IVD devices are typically used in laboratories or point-of-care settings to analyze samples like blood, urine, or tissue. The Synthes RIA System is a surgical tool used directly on the patient during a 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; and to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include spinal fusion, joint arthrodesis, total joint replacement, fracture repair, nonunion, maxillofacial reconstruction, and tumor removal.
Product codes
HTO, NBH
Device Description
Synthes RIA System is a flexible reaming device that consists of a series of disposable tube assemblies, disposable reamer heads, tube assemblies, drive shaft seals and reusable drive shafts. The device is designed for expedited reaming of the medullary canal in preparation for internal fixation. The RIA System is also designed to harvest bone and bone marrow. 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 System is available in various lengths and diameters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Medullary canal, bone graft sites (spinal fusion, joint arthrodesis, total joint replacement, fracture repair, nonunion, maxillofacial reconstruction, tumor removal)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
510(k) Summary
Page _________ of ____ of _2
| Sponsor: | SYNTHES (USA)
1690 Russell Road
Paoli, PA 19301
(610) 647-9700 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes (USA) Reamer Irrigator Aspirator (RIA) System |
| Classification: | Class II, 21 CFR §888.4540, 888.1100
Orthopedic manual surgical instrument
Arthroscope and Accessories |
| Predicate Device: | Synthes RIA System
Spine-Tech Bone Harvester |
| Device Description: | Synthes RIA System is a flexible reaming device that consists of a
series of disposable tube assemblies, disposable reamer heads, tube
assemblies, drive shaft seals and reusable drive shafts. The device
is designed for expedited reaming of the medullary canal in
preparation for internal fixation. The RIA System is also designed
to harvest bone and bone marrow. 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 System is available in various lengths
and diameters. |
| 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; and
to harvest finely morselized autogenous bone and bone marrow for
any surgical procedure requiring bone graft to facilitate fusion
and/or fill bone defects. These procedures include spinal fusion,
joint arthrodesis, total joint replacement, fracture repair, nonunion,
maxillofacial reconstruction, and tumor removal. |
| Substantial
Equivalence: | Documentation is provided which demonstrates that the Synthes RIA
System, is substantially equivalent* to other legally marketed
devices. |
| | * The term "substantially equivalent" as used in this 510(k)
notification is limited to the definition of substantial equivalence
found in the Food, Drug, and Cosmetic Act, as amended and as
applied under 21 CFR 807, Subpart E, under which a device can be
marketed without pre-market approval or reclassification. A |
1
etermination of substantial equivalency under this notification is
not intended to have any bearing whatsoever on the resolution of
patent infringement suits or any other patent matter. No statements
related to, or in support of substantial equivalence herein shall be
construed as an admission against interest under the US Patent
Laws or their application by the courts.
ತಿ ವೈ ಕ
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
MAR 1 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Sheri L. Musgnung Regulatory Affairs Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K042899
Trade/Device Name: Synthes (USA) Reamer Irrigator Aspirator (RIA) System-Expanded Indications Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HTO and NBH Dated: March 4, 2005 Received: March 7, 2005
Dear Ms. Musgnung:
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 10 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Sheri L. Musgnung
This letter will allow you to begin marketing your device as described in your Sccion 510(k) I his letter will anow you to begin manketing your and equivalence of your device to a legally premarket notheation. The PDA midning of basification 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 If you desire specific advice ion your as note the regulation entitled by the regulation entitled, contact the Office of Complaned at (210) = 16 = 1 = 1 807.97). You may obtain "Misbranding by relective to promance nobilities under the Act from the Division of Small other general Information on your responsion.com and its toll-free number (800) 638-204 or http:// (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Lester Morton
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
| 510(k) Number (if known): | K042899 |
|---|---|
| Device Name: | Synthes (USA) Reamer Irrigator Aspirator (RIA) System - |
| Expanded Indications | |
| Indications: | 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; and to harvest finely morselized autogenous bone and | |
| bone marrow for any surgical procedure requiring bone graft to | |
| facilitate fusion and/or fill bone defects. These procedures | |
| include spinal fusion, joint arthrodesis, total joint replacement, | |
| fracture repair, nonunion, maxillofacial reconstruction, and tumor | |
| removal. |
Prescription Use _ X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Zack Attin
. Division Sign-Off) Division of Concell, Restorative and Neurological Devices
Number K042879