(149 days)
Not Found
Not Found
No
The description focuses on manual, single-use instruments for delivering bone cement and explicitly states "Not Found" for mentions of AI, DNN, or ML, as well as training/test set descriptions and performance studies typically associated with AI/ML devices.
No.
The device is a delivery system for bone cement, described as "general surgical instruments" that "does not contain any bone cement material." It facilitates a therapeutic procedure (delivery of bone cement) but is not itself a therapeutic agent or device that directly treats a condition.
No
The device is described as a delivery system for bone cement, consisting of general surgical instruments. Its stated purpose is to deliver material to a surgical site, not to diagnose a condition or disease.
No
The device description explicitly states it consists of "general surgical instruments" and "manual, single-use disposable instruments," indicating it is a hardware-based system for delivering bone cement.
Based on the provided information, the EQUESTRA™ Delivery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to deliver bone cement to a surgical site in orthopedic procedures. This is a surgical delivery system, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description clearly states it's a system of general surgical instruments for injecting bone cement. It does not contain or analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases, or providing diagnostic information.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. The EQUESTRA™ Delivery System does not fit this definition.
N/A
Intended Use / 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.
Product codes
HRX, HXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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.
Not Found
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
Not Found
§ 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.
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.
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Classification Name: Orthopedic Manual Surgical Instrument III.
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Regulation Number: 888.4540, 878.4800 and 878.4200 IV.
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.
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