(181 days)
Not Found
No
The document describes a mechanical syringe used for a physical technique (loss of resistance) and makes no mention of AI, ML, or any computational analysis.
No
The device is solely used to verify needle tip placement using the loss of resistance technique and is not intended for injection or aspiration, nor does it treat or diagnose a disease or condition.
No.
The device is used to verify needle tip placement by the loss of resistance technique, which is a method of confirmation rather than diagnosing a medical condition.
No
The device description clearly states it is a physical syringe, a single-use hardware device, and mentions materials and biological qualification safety tests, which are relevant to hardware components.
Based on the provided information, the Busse Loss of Resistance Syringe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for verifying needle tip placement in the epidural space using the loss of resistance technique. This is a procedure performed in vivo (within the body) on a patient.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
- Device Description: The description focuses on the physical characteristics and sterility of the syringe, not on analyzing biological samples.
- Lack of IVD-related information: There is no mention of analyzing samples, reagents, or any other components typically associated with IVD devices.
The device is used directly on a patient during a medical procedure, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Busse 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, it will be filled with air and/or saline during use. The loss of Resistance 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 (comma separated list FDA assigned to the subject device)
CAZ
Device Description
The Busse Loss of Resistance 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 tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Testing: All materials used in the fabrication of the specialty needles were evaluated through biological qualification safety tests. The biocompatibility tests performed were L929 Men Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay and Hemolysis - Rabbit Blood 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): 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.
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 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
Image /page/0/Picture/0 description: The image shows the logo for Busse Hospital Disposables. The logo features the word "busse" in a bold, sans-serif font, with the letters closely spaced together. Below the word "busse" are the words "Hospital Disposables" in a smaller, less bold font. The logo is black and white.
Ko61737
SUMMARY
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Regulatory Affairs Contact: | Muhamad Ansari
Busse Hospital Disposables
PO Box: 11067
75 Arkay Dr.
Hauppauge NY 11788 | DEC 1 8 2006 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Telephone: | 631-435-4711 Ext: 254 | |
| Fax: | 631-435-2849 | |
| Date Summary Revised: | Sept 20th, 2006 | |
| Product Trade Name: | Busse Loss of Resistance Syringe | |
| Common Name: | Loss of Resistance Syringe. | |
| Classification Name: | Conduction Anesthetic | |
| Classification: | Class II, 21 CFR 868.5140 | |
| Product Code: | CAZ | |
| Predicate Device: | B-D Loss of Resistance Syringe - (K925902) | |
| Device Description: | The Busse Loss of Resistance 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 tip. | |
| Intended Use: | The Busse 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, it will be filled with air and/or
saline during use. The loss of Resistance Syringe is not
intended for injection or aspiration. The syringe will be
sold sterile individually packaged, and as part of a
sterile kit. | |
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 each letter connected to the next. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, sans-serif font.
510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
Summary of Testing: All materials used in the fabrication of the specialty needles were evaluated through biological qualification safety tests. The biocompatibility tests performed were L929 Men Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay and Hemolysis - Rabbit Blood 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:
thilhamed C. Oysir (Signature)
(printed name) Muhamad Ansari Title: Director of Regulatory Affairs Date: 9/2010CP
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Muhamad Ansari Director of Regulatory Affairs Robert Busse & Company, Incorporated Corporate Offices P.O. Box 11067 Hauppauge, New York 11788
DEC 1 8 2006
Re: K061737
Trade/Device Name: Busse Loss of Resistance Syringe Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: November 20, 2006 Received: November 22, 2006
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 1 Register.
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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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
4
INDICATIONS FOR USE
510(k) Number (if known): _ K061737
Device Name: Busse Loss of Resistance Syringe.
Indication for Use: The Busse 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, it will be filled with air and/or saline during use. The loss of Resistance 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 – CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mohd. Wahid for An Ibrahim
n of Anesdiesiology, General Hospital, on Control. Dental D