(59 days)
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.
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.
Here's an analysis of the provided text regarding the Synthes Reamer Irrigator Aspirator (RIA) System, focusing on acceptance criteria and study information:
Analysis of Acceptance Criteria and Device Performance Study
The provided document is a 510(k) summary for the Synthes (USA) Reamer Irrigator Aspirator (RIA) System (K013527). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific performance metrics and acceptance criteria as might be seen for novel high-risk devices.
Therefore, the document does not contain explicit acceptance criteria or a study demonstrating the device meets those criteria in the way envisioned by the prompt's structured questions. Instead, the "study" is the comparison to the predicate device, K993335 (Synthes (USA) Reamer Irrigator Aspirator (RIA) System). The primary "acceptance criteria" in a 510(k) context for a device like this are that it is substantially equivalent in terms of intended use, technological characteristics, and safety and effectiveness information to the predicate device.
Given this, I will address the prompt's questions based on the information available and clarify what is not present in a standard 510(k) for a device of this type.
1. Table of Acceptance Criteria and Reported Device Performance
As explained above, explicit, quantitative acceptance criteria with specific performance metrics are not typically found in a 510(k) summary for devices like the Synthes RIA System, which relies on substantial equivalence to a predicate. The "performance" demonstrated is that the modified device performs as intended and is substantially equivalent to its predecessor.
| Acceptance Criteria Category (Implied by 510(k)) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Intended Use | "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." - Identical to predicate. |
| Technological Characteristics | "flexible reaming device that consists of a series of disposable tube assemblies, disposable reamer heads and reusable drive shafts." Device is "available in reaming diameters ranging from 10 to 19 mm and effective reaming lengths ranging from 200 to 580 mm." - Equivalent to predicate, indicating no significant changes that would alter safety or effectiveness. |
| Safety and Effectiveness | The FDA’s clearance of K013527 indicates that the agency found the device to be as safe and effective as the predicate device (K993335) for its stated intended use. No new safety or effectiveness concerns were raised in comparison to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) submission. There was no "test set" of patients or cases in a clinical study sense. The demonstration of substantial equivalence is based on device description, technical specifications, and comparison to the predicate.
- Data Provenance: Not applicable. No clinical data or patient data is mentioned or used for this 510(k) clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No "test set" or external experts were used to establish ground truth for a performance study. Clinical expertise during the FDA review process would be from FDA reviewers evaluating the submission.
4. Adjudication Method for the Test Set
- Not applicable. No "test set" requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- Not applicable. The Synthes RIA System is a mechanical surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or assessment of human improvement with AI assistance is entirely irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. As noted above, this device is a mechanical surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
- Not applicable in the clinical study sense. The "ground truth" for a 510(k) in this context is the established safety and effectiveness of the predicate device, which the new device is compared against.
8. The Sample Size for the Training Set
- Not applicable. As a mechanical surgical instrument, there is no "training set" in the machine learning or AI context. Device design and engineering principles, along with manufacturing standards, guide its development.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no training set for this type of device.
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Summary of Safety and Effectiveness Information: 3.
DEC 21 2001
510(k) SUMMARY
| Submitter: | Synthes (USA)1690 Russell RoadPaoli, 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 thatconsists of a series of disposable tube assemblies,disposable reamer heads and reusable drive shafts. Thedevice is designed for expedited reaming of the medullarycanal in preparation for internal fixation. The free-rotatingreamer head attaches to the distal end of the tube assembly.Ports in the manifold of the tube assembly allowsimultaneous irrigation and aspiration through the tubeassembly during the reaming process. Irrigating fluid ispassed through the cannula of the drive shaft and reamerhead and aspiration is drawn through ports of the retainerand aspiration tube. The RIA device is available in reamingdiameters ranging from 10 to 19 mm and effective reaminglengths ranging from 200 to 580 mm. |
| Intended Use: | Synthes RIA System is intended to clear the medullarycanal of bone marrow and debris and to effectively size themedullary canal for the acceptance of an intramedullaryimplant or prosthesis. |
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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.
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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
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- 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, Restorativeand Neurological Devices | |
| Special 510(k): Synthes RIA SystemCONFIDENTIAL | |
| 510(k) Number | K013527 |
| 000004 |
N/A