(153 days)
The Epidural Catheter is intended for administration of local anesthetics into the epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.
The Busse Epidural Catheter is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The Catheter will also be sold as a non-sterile product to kit packers, who then may sterilize the catheter as part of a kit.
The provided document is a 510(k) summary for the Busse Epidural Catheter, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain information about a study with acceptance criteria for device performance in the way a clinical trial or algorithm performance study would. Instead, it details biocompatibility testing for the materials used in the catheter.
Here's an breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| L929 Men Elution Test | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Kligman Maximization Test | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Intracutaneous Injection Test | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Systemic Injection Test | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Salmonella Typhimurium; and Escherichia Coli Reverse Mutation Assay | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Hemolysis - Rabbit Blood | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| 14 Day Repeat Dose Intravenous Toxicity Study (Sub - Chronic) | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
| Intramuscular Implantation Test - ISO | Acceptable for intended use | Met the testing requirements and were found to be acceptable |
Note: The document states "These materials have met the testing requirements and were found to be acceptable for the intended use" for all listed tests, implying that meeting the standard for each test constitutes the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This document describes biocompatibility testing of materials, not a test set of data for an AI/algorithm. Therefore, concepts like sample size for a test set, and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The tests listed are laboratory-based assessments of material interaction with biological systems.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. Ground truth, in the context of expert review, is not relevant for the biocompatibility tests described. These tests have established scientific methods and pass/fail criteria.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods are typically used when there's subjective interpretation, like in a clinical image review. Biocompatibility tests have objective results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This document is for a physical medical device (epidural catheter), not an AI/algorithm where human reader performance would be evaluated.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not an AI/algorithm device, so standalone performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for the biocompatibility tests is the established scientific methodology and criteria for each specific test (e.g., cell viability in L929, skin reaction scores in Kligman, hemolytic index in rabbit blood). Pathology would be relevant if the study involved tissue analysis from implantation, which is part of the Intramuscular Implantation Test. Outcomes data is not mentioned in these specific tests.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI/algorithm, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there's no training set, this question is not relevant.
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SUMMARY
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS BUSSE EPIDURAL CATHETER
| Regulatory Affairs Contact: | Muhamad AnsariBusse Hospital DisposablesPO Box: 1106775 Arkay Dr.Hauppauge NY 11788 | JUL 19 2007 |
|---|---|---|
| Telephone: | 631-435-4711 Ext: 254 | |
| Fax: | 631-435-2849 | |
| Date Summary Prepared: | February 8th 2007 | |
| Product Trade Name: | Busse Epidural Catheter | |
| Common Name: | Epidural Catheter | |
| Classification Name: | Anesthesia Conduction Catheter | |
| Classification: | Class II, 21 CFR 868.5120 | |
| Product Code: | BSO | |
| Predicate Device: | Micor - Conduction Catheter -- (K001717) | |
| Device Description: | The Busse Epidural Catheter is a single use device,which is sold as sterile individually packaged andsterile packaged inside a kit/procedure tray. | |
| Intended Use: | The Epidural Catheter is intended for administration oflocal anesthetics into the epidural space. Busserecommends the removal and/or replacement of thecatheter every 72 hours.The epidural catheter will be sold sterile individuallypackaged, and as part of a sterile kit.The Catheter will also be sold as a non-sterile productto kit packers, who then may sterilize the catheter aspart of a kit. |
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510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Summary of Testing: | All materials used in the fabrication of the epidural catheterwere evaluated through biological qualification safety tests.The biocompatibility tests performed were L929 Men ElutionTest, Kligman Maximization Test,Intracutaneous Injection Test, Systemic Injection Test,Salmonella Typhimurium; and Escherichia Coli ReverseMutation Assay, Hemolysis - Rabbit Blood, 14 Day RepeatDose Intravenous Toxicity Study (Sub - Chronic),Intramuscular Implantation Test - ISOThese materials have met the testing requirements and werefound to be acceptable for the intended use. |
|---|---|
| Technological Characteristics:[21 CFR 807.92(a)(6)] | The subject device has the same TechnologicalCharacteristics as a legally marketed predicate device. |
| Conclusion:[21 CFR 807.92(b)(3)] | The above statements are accurate representations of the deviceBusse intents to market.Based on all the testing and comparison Busse believes thesubject device is substantially equivalent to the predicatedeviceAll data and information submitted in this premarketnotification is truthful and accurate and no material fact hasbeen omitted. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2007
Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables P.O. Box 11067 Hauppauge, New York 11788
Re: K070465
Trade/Device Name: Busse Epidural Catheter Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: July 6, 2007 Received: July11, 2007
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 vours.
Cars
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
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INDICATIONS FOR USE
510(k) Number (if known): __k ك ك ك ك
Device Name: Busse Epidural Catheter.
Indication for Use: The Epidural Catheter is intended for administration of local anesthetics into the epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.
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)
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Division of Anesthesiology, General Hospital
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510(k) Number: K070465
§ 868.5120 Anesthesia conduction catheter.
(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).