(57 days)
The SPECTRA-LOR, Loss of Resistance Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.
The construction of the SPECTRA-LOR, Loss of Resistance Syringe is similar to that of a standard piston syringe; it has a barrel, a plunger and a bung. The barrel has graduations which correspond to a capacity of 10 ml and is available in a Luer Lock or Luer Slip tip.
The provided text is a 510(k) summary for the SPECTRA-LOR, Loss of Resistance Syringe. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific acceptance criteria.
The document explicitly states: "The SPECTRA-LOR, Loss of Resistance Syringe is equivalent to the predicate device, AVID-NIT Loss of Resistance Syringe in materials of construction, intended use, capacity and bench testing." This indicates that the regulatory clearance was based on substantial equivalence to a predicate device, rather than new studies proving pre-defined acceptance criteria for the SPECTRA-LOR syringe's performance.
Therefore, I cannot provide the requested information from the text.
If this were a typical AI device submission, the response would look like this (but based on the actual information provided, such details are absent):
1. Table of Acceptance Criteria and Reported Device Performance
(No specific acceptance criteria or performance metrics were provided in the document for the SPECTRA-LOR syringe. Its approval is based on substantial equivalence to a predicate device.)
2. Sample Size Used for the Test Set and Data Provenance
(Not applicable, as no dedicated study with a test set was described to prove specific performance metrics for the SPECTRA-LOR syringe.)
3. Number of Experts Used to Establish Ground Truth and Qualifications
(Not applicable, as no specific study involving expert-established ground truth was described.)
4. Adjudication Method for the Test Set
(Not applicable.)
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
(Not applicable. This device is a physical syringe, not an AI-assisted diagnostic tool.)
6. Standalone (Algorithm Only) Performance Study
(Not applicable. This device is a physical syringe, not an algorithm.)
7. Type of Ground Truth Used
(Not applicable, as no ground truth was established for performance metrics in a study for this device.)
8. Sample Size for the Training Set
(Not applicable. This device is a physical syringe, not a machine learning model requiring a training set.)
9. How the Ground Truth for the Training Set Was Established
(Not applicable.)
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510(K) SUMMARY KOX (524
JUL 2 9 2008
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990, 21 CFR 807.92.
| Classification Name: | Syringe, Piston |
|---|---|
| Common Name: | Piston Syringe |
| Proprietary Name: | SPECTRA-LOR, Loss of Resistance Syringe |
| Classification: | Class II |
| Product Code: | 80FMF |
| Regulation Number: | 880.5860 |
Establishment Name, Contact & Registration Number:
Name:
Spectra Medical Devices, Inc. 260-F Fordham Road Wilmington, MA 01887 Tele: 978-657-0889, Ext. Fax: 978-657-4339
Contact:
Scott Henderson
Intended Use:
The SPECTRA-LOR, Loss of Resistance Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.
Predicate Device: AVID-NIT Loss of Resistance Syringe, FDA 510(K) # K001731
Device Description:
The construction of the SPECTRA-LOR, Loss of Resistance Syringe is similar to that of a standard piston syringe; it has a barrel, a plunger and a bung. The barrel has graduations which correspond to a capacity of 10 ml and is available in a Luer Lock or Luer Slip tip.
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510(K) SUMMARY K
Equivalent Predicate Device:
The SPECTRA-LOR, Loss of Resistance Syringe is equivalent to the predicate device, AVID-NIT Loss of Resistance Syringe in materials of construction, intended use, capacity and bench testing.
SECTION 5, PAGE 4
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Scott Henderson International Engineering Manager Spectra Medical Devices, Incorporated 4501 Greendale Drive Williamsburg, Virginia 23188
JUL 2 9 2008
Re: K081524
Trade/Device Name: SPECTRA-LOR Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: May 30, 2008 Received: June 2, 2008
Dear Mr. Henderson:
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.
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Page 2 - Mr. Henderson
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
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 (if known): K081524
Device Name: SPECTRA - LOR
Indications for Use:
The "SPECTRA - LOR", Loss of Resistance Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Charles Zink
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081524
SECTION 3, Page 1
§ 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).