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.

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.

AI/ML Overview

This document describes a 510(k) premarket notification for the Busse Plastic LOR Syringe. The information provided heavily emphasizes the device's substantial equivalence to a predicate device and safety testing of its materials, rather than detailed performance criteria or clinical study results in the context of typical AI/ML device evaluations.

Therefore, many of the requested categories for acceptance criteria and the study proving device meets acceptance criteria cannot be fully addressed in the way they would for an AI/ML or diagnostic device. I will extract what is available and note where information is absent or not applicable given the nature of the submission.

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Derived from safety and technological equivalence)	Reported Device Performance
Biocompatibility for materials used in fabrication:
- Kligman Maximization Test	Met testing requirements.
- Intracutaneous Injection Test	Met testing requirements.
- Systemic Injection Test	Met testing requirements.
- Rabbit Pyrogen Test	Met testing requirements.
- L929 Mem Elution Test	Met testing requirements.
Technological Characteristics:
- Same as legally marketed predicate device (K061737)	Confirmed.
Intended Use:
- For use in conjunction with an epidural needle to verify needle tip placement in the epidural space by the loss of Resistance technique. To be filled with air and/or saline. Not for injection or aspiration.	Intended use matches predicate; validated implicitly by substantial equivalence.
Sterility:	Sold as sterile.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not explicitly provided in the document. The testing mentioned (biocompatibility tests) are bench/laboratory tests, not clinical performance studies with patient data.

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 information is not applicable. The "ground truth" for this type of device (a mechanical/physical medical device) is based on its physical properties, material safety, and functional equivalence, not on expert interpretation of clinical data in the same way an AI/ML diagnostic device would be. The biocompatibility tests have established protocols and pass/fail criteria, likely interpreted by laboratory specialists.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept pertains to resolving discrepancies in expert interpretations for establishing ground truth in diagnostic studies, which is not relevant for this device's submission.

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 not an AI-assisted device, nor is it a diagnostic device that would typically undergo MRMC studies. The submission is for a physical medical device (syringe).

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's submission is based on:

Material Biocompatibility Standards: Compliance with established biological qualification safety tests (Kligman Maximization, Intracutaneous Injection, Systemic Injection, Rabbit Pyrogen, L929 Mem Elution Tests).
Technological Equivalence: Direct comparison to a legally marketed predicate device (Loss of Resistance Syringe - K061737) to demonstrate similar design, materials, and functional characteristics.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device being a physical syringe. The submission relies on substantial equivalence and material safety testing.

9. How the ground truth for the training set was established

Not applicable, as there is no training set. The "ground truth" for the device's suitability is established through adherence to recognized biocompatibility standards and demonstration of technological equivalence to a predicate device already on the market.

Summary

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Iusse
Hospital Disposables

Koron 4

SUMMARY

JUL - 9 2008

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Busse Plastic LOR Syringe

Regulatory Affairs Contact:	Muhamad AnsariBusse Hospital DisposablesPO Box: 1106775 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 issold as sterile individually packaged and sterilepackaged inside a kit/procedure tray. The syringe willbe available in luer lock and luer slip.
Intended Use:	Indication for Use: The plastic LOR syringe is intendedfor use in conjunction with an epidural needle, to verifythe needle tip placement in the epidural space by theloss of Resistance technique. The loss of ResistanceSyringe is not intended for injection or aspiration.

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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 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 Test2. Intracutaneous Injection Test3. Systemic Injection Test4. Rabbit Pyrogen Test5. L929 Mem Elution TestThese 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 deviceAll 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 AffairsDate: 3/13/08

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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 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.

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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 (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

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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

Regulation Number and Section

§ 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).