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.

Device 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.

AI/ML Overview

Here's an analysis of the provided text regarding the EQUESTRA™ Fluid Delivery System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than conducting a new clinical study with specific acceptance criteria for device performance as one might see for a novel, high-risk device or an AI/ML product. Therefore, many of the requested categories (like sample size, ground truth, MRMC studies, etc.) are not applicable to this type of submission.

The EQUESTRA™ Fluid Delivery System is a collection of general surgical instruments (bone tamps, stylets, and cannulas) designed to deliver legally cleared bone cement during orthopedic procedures. It does not contain any bone cement itself.

Since this is a submission based on substantial equivalence to existing Class I exempt instruments, the "acceptance criteria" are primarily related to general device safety and effectiveness as demonstrated by the predicate devices, rather than specific performance metrics measured in a new study.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Equivalence to Predicate Devices: - Ability to provide a percutaneous means of delivering bone cement. - Mechanical properties suitable for their intended use (e.g., bone tamps for tamping, stylets for guiding). - Single-use disposable.	The submission asserts that the EQUESTRA™ Fluid Delivery System is substantially equivalent to various Class I exempt instruments including bone tamps, cannulas and stylets. This implicitly means it meets the functional capabilities and safety profiles of these predicate devices. Specific performance values (e.g., force required for tamping, flow rate through cannula) are not provided as this is not a de novo study.
Biocompatibility: (Implied for patient contact devices)	While not explicitly stated as an "acceptance criteria," biocompatibility would be an inherent requirement for any surgical instrument. The substantial equivalence claim suggests it meets the same biocompatibility standards as its predicates.
Sterility: (Implied for surgical instruments)	Also not explicitly stated as an "acceptance criteria," sterility is a fundamental requirement. The "single-use disposable" nature implies it is supplied sterile.
Material Safety: (Implied for components)	The materials used would be expected to be safe for their intended use and consistent with materials used in predicate devices.

2. Sample Size for the Test Set and Data Provenance

Not Applicable. No explicit "test set" and corresponding sample size are mentioned for a new study. The demonstration of substantial equivalence relies on comparison to existing, already-marketed predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. Given the nature of a 510(k) for general instruments demonstrating substantial equivalence, there was no separate "ground truth" establishment for performance metrics by independent experts, as would be done for a diagnostic or AI device. The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices.

4. Adjudication Method

Not Applicable. No adjudication method is described as there was no study requiring expert consensus or adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is typically performed for imaging or diagnostic devices where human readers interpret results, sometimes with AI assistance. The EQUESTRA™ system is a set of physical surgical instruments, so an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study

No. This device is hardware (surgical instruments), not an algorithm or software. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used

The "ground truth" in the context of this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The applicant is asserting that the EQUESTRA™ system is equivalent to these already-approved devices, rather than establishing new performance metrics.

8. Sample Size for the Training Set

Not Applicable. There is no "training set" as this device does not involve an AI/ML algorithm or a new performance study that would require statistical training data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. (As above, no training set).

Summary

{0}------------------------------------------------

K04o4f3

[III]] 2 3 2004

EQUESTRA™ Flaid Lelivery System 510(k) Summary June 2004

Medtronic Sofamor Danek I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Richard W. Treharne, PhD Contact: Senior Vice President Regulatory Affairs
Proprietary Trade Name: EQUESTRATM Fluid Delivery System II.
Classification Name: Orthopedic Manual Surgical Instrument III.
Regulation Number: 888.4540, 878.4800 and 878.4200 IV.

V. Product Description

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 EQUESTRA™ Delivery System to be substantially equivalent to various Class I exempt instruments including bone tamps, cannulas and stylets.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which is a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

JUL 2 3 2004

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: K040483

Trade/Device Name: EQUESTRA™ Fluid Delivery System Regulation Number: 21 CFR 888.1100, 21 CFR 888.4540 Regulation Name: Arthroscope; Orthopedic manual surgical instrument Regulatory Class: II Product Code: HRX, HXG Dated: June 22, 2004 Received: June 23, 2004

Dear Dr. Treharne:

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) 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2 - Richard W. Treharne, Ph.D.

This letter will allow you to begin 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

Mark N Milkenm

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

{3}------------------------------------------------

510(k) Number (if known): K040483

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)

for Mark N Millkum

Division of General, Restorative, and Neurological Devices

510(k) Number K040983

Regulation Number and Section

§ 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.