(29 days)
The EQUESTRA™ Delivery System is intended to provide surgeons with a percutaneous means of delivering legally cleared bone cement to the surgical site in orthopedic procedures.
The EQUESTRA™ Fluid Delivery System is designed to provide surgeons with a means to inject commercially cleared bone cement to the surgical site in orthopedic procedures. The EQUESTRA™ Fluid Delivery System does not contain any bone cement material, as this system only consists of general instruments.
The EQUESTRA™ Fluid Delivery System consists of a variety of general surgical instruments. The system reservoirs are supplied empty as the system itself does not include any bone cement. Included in the system are bone tamps and stylets. All of the system components are manual, single-use disposable instruments.
The purpose of this submission was to add modified instruments to the EQUESTRA™ Fluid Delivery System.
This document describes the K043568 EQUESTRA™ Fluid Delivery System, which is a set of instruments used to deliver legally cleared bone cement in orthopedic procedures.
Based on the provided text, there is no acceptance criteria or study data presented that proves the device meets specific performance metrics.
The submission is a 510(k) Pre-market Notification seeking substantial equivalence. The core of this type of submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than proving its performance against specific, quantifiable acceptance criteria through an independent study.
Here's a breakdown based on your requested information:
1. A table of acceptance criteria and the reported device performance:
- Not applicable. The document does not describe acceptance criteria for specific performance metrics (e.g., flow rate, pressure, volume delivery accuracy) nor independent performance results against such criteria. The submission relies on demonstrating substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No test set or associated data provenance is described for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a manual surgical instrument and does not involve AI or human "readers" in the context of image interpretation or diagnostic performance. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The submission focuses on substantial equivalence based on device design and intended use compared to a predicate, not on a ground truth for a diagnostic or performance outcome.
8. The sample size for the training set:
- Not applicable. This device is a manual surgical instrument; there is no "training set" in the context of machine learning or statistically powered performance studies.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
In summary:
The K043568 submission for the EQUESTRA™ Fluid Delivery System is a pre-market notification (510(k)) that established substantial equivalence to an already cleared predicate device (K040483). This means the device was determined to be as safe and effective as the predicate without necessarily conducting independent, de novo performance studies with acceptance criteria, test sets, or ground truth establishment. The "proof" of meeting any "criteria" is the demonstration that the new instruments are sufficiently similar to the previously cleared ones.
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EQUESTRA™ Fluid Delivery System 510(k) Summary December 2004
JAN 2 5 2005
| I. Company: | Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133 |
|---|---|
| ------------- | -------------------------------------------------------------------------------- |
Contact: Richard W. Treharne, PhD Senior Vice President Regulatory Affairs
II. Proprietary Trade Name: EQUESTRA™ Fluid Delivery System
Classification Name: Orthopedic Manual Surgical Instrument III.
IV. Regulation Number: 888.4540, 878.4800 and 878.4200
V. Product Description
The EQUESTRA™ Fluid Delivery System is designed to provide surgeons with a means to inject commercially cleared bone cement to the surgical site in orthopedic procedures. The EQUESTRA™ Fluid Delivery System does not contain any bone cement material, as this system only consists of general instruments.
The EQUESTRA™ Fluid Delivery System consists of a variety of general surgical instruments. The system reservoirs are supplied empty as the system itself does not include any bone cement. Included in the system are bone tamps and stylets. All of the system components are manual, single-use disposable instruments.
The purpose of this submission was to add modified instruments to the EQUESTRA™ Fluid Delivery System.
VII Indications
The EQUESTRA™ Delivery System is intended to provide surgeons with a percutaneous means of delivering legally cleared bone cement to the surgical site in orthopedic procedures.
VIII Substantial Equivalence
Documentation was provided which demonstrated the subject EQUESTRA™ instruments to be substantially equivalent to the EQUESTRA™ Fluid Delivery System instruments previously cleared by the agency in K040483 (SE 07/23/04).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & 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 three human profiles facing to the right, with flowing lines beneath them, possibly representing water or movement.
JAN 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132
Re: K043568
Trade/Device Name: EQUESTRA™ Fluid Delivery System Regulation Number: 21 CFR 888.4540 Regulation Name: Orthopedic manual surgical instrument Regulatory Class: II Product Code: HRX and HXG Dated: December 22, 2004 Received: December 27, 2004
Dear Dr. Treharne:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreases) is the enactment date of the Medical Device Amendments, or to conniner of Hay 2016 to 112) 2011 accordance with the provisions of the Federal Food, Drug, de nocs that have been resuire approval of a premarket approval application (PMA). and Costiere for (110) was the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains 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 If your device is elassined controls. Existing major regulations affecting your device can may be dayses to been it ween 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 r rease of acrised 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 or any 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.
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Page 2 - Richard W. Treharne, Ph.D. .
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough manisoning of substantial equivalence of your device to a legally premaired 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 If you desire specific advice for your 2011 5. Also, please note the regulation entitled, Colliact the Office of Compilance in (21 m) (21CFR Part 807.97). You may obtain Misblaining by reference to premains on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or 1011) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
uriam C. Provost
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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510(k) Number (if known):
Device Name: EQUESTRA™ Fluid Delivery System
Indications for Use:
The EQUESTRA™ Delivery System is intended to provide surgeons with a percutaneous means of delivering legally cleared bone cement to the surgical site in orthopedic procedures.
Prescription Use X (Part 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)
Miriam C. Provost
Division of General, Restorative, and Neurological Devices
510(k) Number_Ko43568
00053
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.