(227 days)
The epidural catheter is intended for administration of local anesthetics into epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.
The Epidural Catheter kit consists of clear tubing with a black radiopaque stripe, a Thread assist guide, a Connector Gasket, and a Tuohy Borst adapter catheter connection. All inserted in a Polvethylene bag. The catheter is marked at 5 cm from the tip with 1 cm increments up to 20 cm. The 10 cm mark is indicated by two marks, the 15 cm by three marks, and the 20 cm by four marks. The Catheter will be available 20 Gauge, with a nominal length of 36 inches. It will be available in open tip or closed tip with 3 eyes. As an extra safety feature, the tip of the catheter is incorporated with a marking to assure the completed catheter has been removed.
The provided text describes a 510(k) premarket notification for a medical device, the Busse Epidural Catheter Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical trial or a deep learning algorithm's performance study.
Therefore, the information typically requested in your prompt (e.g., acceptance criteria tables, sample sizes for test sets, expert-driven ground truth, MRMC studies, standalone algorithm performance) is not applicable or present in this 510(k) summary.
Here's why and what information is available:
- 510(k) Submissions are about Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove it meets a set of predefined performance "acceptance criteria" in the way a novel AI algorithm might.
- Focus on Bench Testing and Biocompatibility: The "study" here consists of bench tests and biocompatibility evaluations, demonstrating that the device materials and physical performance are acceptable and comparable to the predicate.
Information provided in the text that is relevant to your request (though not directly "acceptance criteria" for an AI or clinical study):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by testing) | Reported Device Performance |
|---|---|
| Biocompatibility (Safety) | All materials met testing requirements and were found to be acceptable for intended use (Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Rabbit Pyrogen Test, L929 Mem Elution Test, Hemolysis Test, Subacute Toxicity). |
| Performance (Functionality) | All materials met testing requirements and were found to be acceptable for intended use (Liquid Leakage, Kink Test, Flow Rate, General Tensile Testing, Pull Test). |
| Material Equivalence | Design is the same as the predicate except for minor material changes; attached testing demonstrates materials do not affect performance. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the bench tests or biocompatibility tests. These are typically laboratory tests on manufactured units or material samples, not patient data.
- Data Provenance: Not applicable in the sense of patient data. The "data" comes from laboratory testing of the device materials and components.
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)
- Not Applicable: "Ground truth" in the context of expert consensus on medical images or clinical outcomes is not relevant for this type of device submission. The "truth" is established by adherence to recognized testing standards for material biocompatibility and physical performance characteristics.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are for resolving discrepancies in expert interpretations, which is not part of this submission. The tests performed have clear pass/fail criteria based on established laboratory protocols.
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
- No, not done: This is a submission for a physical medical device (an epidural catheter kit), not an AI-powered diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, not done: This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Laboratory Standard Compliance: The "ground truth" or "reference standard" for this submission is compliance with established biocompatibility testing standards (e.g., ISO 10993 series, though not explicitly stated that exact standard, it's implied for such tests) and engineering performance specifications for devices of this type.
8. The sample size for the training set
- Not Applicable: There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable: There is no "training set."
Summary of the "Study" mentioned:
The "study" referenced in the 510(k) summary is a series of laboratory-based biocompatibility tests and performance tests conducted on the Busse Epidural Catheter and its materials. The purpose of these tests was to demonstrate that the device materials are safe for patient contact and that the device performs functionally as expected, showing substantial equivalence to the predicate device. The document explicitly states: "All materials used in the fabrication of the epidural catheter were evaluated through biological qualification safety tests" and "These materials have met the testing requirements and were found to be acceptable for the intended use."
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Image /page/0/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 close together. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, sans-serif font. The logo is black and white.
AUG 0 6 2010
510(k) Summary
Regulatory Affairs Contact:
Muhamad Ansari Busse Hospital Disposables PO Box: 11067 75 Arkay Dr. Hauppauge NY 11788
Telephone:
Fax:
Date Summary Prepared:
Product Trade Name:
Common Name:
Classification Name:
Predicate Device:
December 17, 2009
631-435-2849
631-435-4711 Ext: 254
Busse Epidural Catheter Kit
Epidural Catheter
Class II, 21 CFR 868.5120, Product code BSO
Micor Conduction Catheter, K001717, Micor Inc.
Device Description:
The Epidural Catheter kit consists of clear tubing with a black radiopaque stripe, a Thread assist guide, a Connector Gasket, and a Tuohy Borst adapter catheter connection. All inserted in a Polvethylene bag. The catheter is marked at 5 cm from the tip with 1 cm increments up to 20 cm. The 10 cm mark is indicated by two marks, the 15 cm by three marks, and the 20 cm by four marks. The Catheter will be available 20 Gauge, with a nominal length of 36 inches. It will be available in open tip or closed tip with 3 eyes. As an extra safety feature, the tip of the catheter is incorporated with a marking to assure the completed catheter has been removed.
Intended Use:
The epidural catheter is intended for administration of local anesthetics into epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.
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busse
Technological Characteristics:
The design of the proposed Catheter is the same as the predicate device, except for the minor changes in the material used. The material does not effect the performance of the device, as attached testing demonstrate.
Summary of Testing:
All materials used in the fabrication of the epidural catheter were evaluated through biological qualification safety tests.
The biocompatibility tests performed were:
-
- Kligman Maximization Test
-
- Intracutaneous Injection Test
-
- Systemic Injection Test
- Rabbit Pyrogen Test 4.
- റ്റ് L929 Mem Elution Test
- ം. Hemolysis Test
- Subacute Toxicity 7.
These materials have met the testing requirements and were found to be acceptable for the intended use.
Summary of Performance Testing:
Busse Epidural Catheter has been tested for the following performance tests:
-
- Liquid Leakage
-
- Kink Test
-
- Flow Rate
-
- General Tensile Testing
-
- Pull Test
These materials have met the testing requirements and were found to be acceptable for the intended use.
Conclusion:
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.
Official Correspondent:
Mihraef Ohen. (Signature)
Muhamad Ansari
Title: Director of Regulatory Affairs
Date: 6/24/10
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Muhamad Ansari Director of Regulatory Affairs. Busse Hospital Disposables 75 Arkay Drive Hauppauge, New York 11788
AUG 0.6 2010
Re: K093920
Trade/Device Name: Busse Hospital Disposable Epidural Catheter Kit Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: July 29, 2010 Received: July 30, 2010
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ht for
Anthony D. Watson, B.S., M.S., M.B.A. 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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FDA 510(k) Premarket Notification Busse Hospital Disposables - Epidural Catheter Kit
INDICATIONS FOR USE
AUG & 6 2010
510(k) Number (if known):
Device Name: Busse Hospital Disposable Epidural Catheter Kit.
The epidural catheter kit is intended for administration of local anesthetics into epidural space. Busse recommends the removal and/or replacement of the catheter every 72 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
L. Schultze
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
4693920 510(k) Number:
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use_
§ 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).