(110 days)
Not Found
No
The description focuses on a simple mechanical syringe used for a standard medical technique (loss of resistance) and makes no mention of AI, ML, or any computational processing.
No.
The device is used to verify needle tip placement in the epidural space, not to treat a condition or disease. It is explicitly stated that it is "not intended for injection or aspiration," which would be common functions of a therapeutic syringe.
No
Explanation: The device is used to verify needle tip placement by detecting a loss of resistance, which is a method of confirmation rather than diagnosing a condition. It is an aid for a medical procedure, not a diagnostic tool for identifying a disease or condition.
No
The device description clearly states it is a "plastic syringe," which is a physical hardware component. The summary also details biocompatibility testing, which is relevant to physical materials, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Busse Plastic LOR Syringe Function: The intended use of this syringe is to verify needle tip placement within the body (in the epidural space) using a physical technique (loss of resistance). It is not used to analyze a biological sample.
Therefore, based on its intended use and function, the Busse Plastic LOR Syringe does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indication for Use: The plastic LOR 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. The loss of Resistance Syringe is not intended for injection or aspiration.
The Busse Plastic LOR 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; it will be filled with air and/or saline during use. The Busse Plastic LOR syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged and as part of a sterile kit.
Product codes
CAZ
Device Description
The LOR plastic syringe is a single use device which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The syringe will be available in luer lock and luer slip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
All materials used in the fabrication of the specialty needles were evaluated through biological qualification safety tests. The biocompatibility tests performed were:
- Kligman Maximization Test
- Intracutaneous Injection Test
- Systemic Injection Test
- Rabbit Pyrogen Test
- L929 Mem Elution Test
These materials have met the testing requirements and were found to be acceptable for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Loss of Resistance Syringe - (K061737)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
Iusse
Hospital Disposables
Koron 4
SUMMARY
JUL - 9 2008
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Busse Plastic LOR Syringe
| Regulatory Affairs Contact: | Muhamad Ansari
Busse Hospital Disposables
PO Box: 11067
75 Arkay Dr.
Hauppauge NY 11788 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | 631-435-4711 Ext: 254 |
| Fax: | 631-435-2849 |
| Date Summary prepared: | March 13, 2008 |
| Product Trade Name: | Busse Plastic LOR Syringe |
| Common Name: | Conduction Anesthetic |
| Classification: | Class II, 21 CFR 868.5140 |
| Product Code: | CAZ |
| Predicate Device: | Loss of Resistance Syringe - (K061737) |
| Device Description: | The LOR plastic syringe is a single use device which is
sold as sterile individually packaged and sterile
packaged inside a kit/procedure tray. The syringe will
be available in luer lock and luer slip. |
| Intended Use: | Indication for Use: The plastic LOR 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. The loss of Resistance
Syringe is not intended for injection or aspiration. |
.
1
Image /page/1/Picture/0 description: The image shows the logo for "busse Hospital Disposables". The word "busse" is in a bold, sans-serif font, with the letters overlapping each other. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, sans-serif font. The logo is black and white.
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Summary of Testing: All mate rials used in the fabrication of the specialty needles were evaluated through biological qualification safety tests. The biocompatibility tests performed were: | |
|---|---|
| 1. Kligman Maximization Test |
- Intracutaneous Injection Test
- Systemic Injection Test
- Rabbit Pyrogen Test
- L929 Mem Elution Test
These materials have met the testing requirements and were found to be acceptable for the intended use. | |
| Technological Characteristics:
[21 CFR 807.92(a)(6)] | The subject device has the same Technological Characteristics as a legally marketed predicate device. |
| Conclusion:
[21 CFR 807.92(b)(3)] | The above statements are accurate representations of the device Busse intents to market.
Based on all the testing and comparison Busse believes the subject device is substantially equivalent to the predicate device
All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted. |
| Manufacturer: | Busse Hospital Disposables. |
| Official Correspondent: | (Signature) |
| | Muhamad Ansari (printed name)
Title: Director of Regulatory Affairs
Date: 3/13/08 |
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
JUL - 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables, Incorporated 75 Arkay Drive Hauppauge, New York 11788
Re: K080804
Trade/Device Name: Busse Plastic LOR Syringes Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: May 5, 2008 Received: June 18, 2008
Dear Mr. Ansari:
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.
3
Page 2 -Mr. Ansari
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 (240) 276-0120. 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/industry/support/index.html.
Sincerely yours.
TRamuels-Lird, mD for/
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
4
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Busse Plastic LOR Syringes
Indication for Use: The Busse Plastic LOR 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; it will be filled with air and/or saline during use. The Busse Plastic LOR syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged and as part of a sterile kit.
Prescription Use __ X (Per 21 CFR 801Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K680804