(227 days)
For use in diagnosis of herniated or otherwise diseased intervertebral disks in the human spine. This device has not been evaluated for use in vertebroplasty.
The Physician Industries' ACCUMETER. Polycarbonate barrel, plunger, and body, containing display software and electronics; Rubber plunger tip. Sterile (100% EtO) and non-pyrogenic (LAL).
The provided text describes the submission and clearance of a device called the "Physician Industries' ACCUMETER: Piston / control / discography syringe" (K033739). However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Instead, the document details:
- Device Identification: Device name, classification, regulation numbers, product code.
- Predicate Devices: A list of previously cleared devices considered substantially equivalent to the ACCUMETER, and why they are considered SE.
- Description: Materials and sterility of the ACCUMETER.
- Intended Use: For discography procedures involving contrast medium injection to view spinal disks using X-ray or photofluorographic systems, under the direction of a licensed clinician.
- Substantial Equivalence Rationale: General indications, similar characteristics, materials, manufacturing, software to predicates, and lack of adverse events in FDA databases.
- Safety and Effectiveness: Asserts no substantive differences from predicate devices, adherence to quality management systems, and compliance with standards.
- FDA Clearance Letter: Formal communication from the FDA confirming the device's substantial equivalence to legally marketed predicate devices and allowing marketing.
- Indications for Use Statement: A specific declaration for the diagnosis of herniated or otherwise diseased intervertebral disks in the human spine, explicitly stating it has not been evaluated for vertebroplasty.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported performance, or details of a study, as this information is not present in the provided text. The document focuses on the regulatory submission process for substantial equivalence rather than reporting an independent performance study with defined acceptance criteria.
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JUL 1 2 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
PHYSICIAN INDUSTRIES INC. SUBMITTED BY: 3395 West 1820 South Salt Lake City UT 84104 Phone: 801-886-9505, toll free 800-241-2210
- DEVICE NAME ACCUMETER: Piston / control / discography syringe
II (all) Class:
IZG Classification:
892.1730 Regulation Nos ..
02. PREDICATE DEVICES:
- Balloon Inflation Syringe, cleared under K913994 (Feb 04, 1992); Similar controls, . software, and materials. Different intended use.
- Digital Intlation Device (syringe), cleared under K904954 (Jan 16, 1991); Similar . controls, software, and materials. Different intended use.
- Discography Kit, cleared under K960082 (Mar 21, 1996); different material same . intended use.
- Discography Kit, cleared under K910503 (Oct 07, 1991), different material same ● intended use.
All determined to be SE.
-
- DESCRIPTION: The Physician Industries' ACCUMETER.
- Polycarbonate barrel, plunger, and body, containing display software and electronics; ರ
- Rubber plunger tip. o
- Sterile (100% EtO) and non-pyrogenic (LAL). 0
-
- INTENDED USE:
To be used for discography procedures, where the injection of contrast medium into a patient is indicated, for the purpose of viewing an area of the body (spinal disk discography) using x-ray or photoflourographic systems, to assist in diagnosis, under the direction of a licensed clinician.
-
- SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: The Physician Industries' ACCUMETER shares the same general indications for use in discography as the predicates. They share the same or similar basic characteristics, materials, method of assembly / manufacture, features, and similar software of the predicates (applicable 'K' numbers listed above). In addition:
- There is no record of unexpected patient problems or adverse reactions in the FDA's 0 MAUDE / MDR, and Safety Alert databases;
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- 5.2. The device and its components have been tested by independent labs for EMC, I he us no the occapatibility in accordance with ISO10993-1:2003. The device will be subjected to incoming inspection/testing. In-process inspections will be performed during manufacturing by QC. All products will have final inspections prior to sale and will be monitored through the means of our CAPA system.
-
- SAFETY AND EFFECIVENESS: There are no substantive differences between the product defined in this 510(k) submission and the predicate devices. It is similar to the technologies that are currently used in other similar medical devices. It was developed and documented under Physician Industries' Quality Management System, under the Quality System Regulation, 21 CFR Part 820, under design/change control, and is verified/validated to applicable standards/guidance documents, including software. This device family is safe and effective, when used as indicated in the application stated herein, discography, under the direction of a licensed clinician.
- The Physician Industries ACCUMETER shares similar indications for use and characteristics and functional features, and thus is substantially equivalent to the currently marketed predicate devices, cited above.
Signed: Brian Baker
Brian Baker, President PHYSICIAN INDUSTRIES, INC.
Dated: July 01, 2007
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The caduceus is depicted with a staff and a serpent winding around it.
Public Health Service
JUL 1 2 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brian Baker President Physician Industries, Incorporated 3395 West 1820 South Salt Lake City, Utah 84104
Re: K033739
Trade/Device Name: Physician Industries' Accumeter Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 28, 2004 Received: June 1, 2004
Dear Mr. Baker:
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 vour 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 - Mr. Baker
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 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) 594-4618. 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,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K033739
Device Name: Physician Industries' Durameter Syringe Accameter
Indications For Use:
For use in diagnosis of herniated or otherwise diseased intervertebral disks in the human spine. This device has not been evaluated for use in vertebroplasty.
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)
Antin One
(Division Sign-Off) Division of Anesthesiology, General Hospital, Page 1 of Infection Control, Dental Devices
510(k) Number: Ky33739
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).