(181 days)
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.
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.
This document is a 510(k) summary for the Busse Loss of Resistance Syringe, which is a medical device. The information provided heavily focuses on the regulatory submission and equivalency to a predicate device, rather than detailed performance study results that would typically be associated with software or AI-driven medical devices.
Based on the provided text, the device is a physical syringe, not an AI or software-driven product, so many of the questions related to acceptance criteria for software performance, sample sizes for test sets, ground truth establishment, MRMC studies, or training data are not applicable.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for performance in the way one might expect for a diagnostic device (e.g., sensitivity, specificity). Instead, the acceptance criteria for this physical medical device are related to its biocompatibility and functional equivalence to a predicate device.
| Acceptance Criteria Category | Reported Device Performance (Summary of Testing) |
|---|---|
| Biocompatibility | All materials used were evaluated through biological qualification safety tests: 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. |
| Result: Materials met testing requirements and were found acceptable for intended use. | |
| Technological Characteristics | The subject device has the same Technological Characteristics as a legally marketed predicate device (B-D Loss of Resistance Syringe - K925902). |
| Intended Use | The device is intended for use in conjunction with an epidural needle to verify needle tip placement in the epidural space by the loss of Resistance technique. |
| Result: Deemed substantially equivalent to the predicate device for this intended use. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "tests" performed are described as biological qualification safety tests on materials, not clinical performance studies with a test set of patient data from a specific provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable as the device is a physical syringe, not a diagnostic or AI-based device requiring expert ground truth establishment for a test set. The evaluation is based on material testing and comparison to a predicate device. The FDA's review and determination of substantial equivalence are conducted by regulatory experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no test set in the context of diagnostic performance that would require an adjudication method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device (syringe), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, "ground truth" would be established through scientific testing standards and regulatory compliance. For biocompatibility, the ground truth is adherence to established biological qualification safety test protocols and their passing criteria. For technological characteristics, the ground truth is direct comparison and equivalence to a legally marketed predicate device in terms of design, materials, and function for the stated intended use.
8. The sample size for the training set
Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of AI/machine learning for this product.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this physical medical device.
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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 AnsariBusse Hospital DisposablesPO Box: 1106775 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 usedevice, which is sold as sterile individually packagedand sterile packaged inside a kit/procedure tray. Thesyringe will be available in luer lock and luer slip tip. | |
| Intended Use: | The Busse Loss of Resistance Syringe is intended foruse in conjunction with an epidural needle, to verify theneedle tip placement in the epidural space by the loss ofResistance technique, it will be filled with air and/orsaline during use. The loss of Resistance Syringe is notintended for injection or aspiration. The syringe will besold sterile individually packaged, and as part of asterile kit. |
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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
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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
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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
§ 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).