(227 days)
Not Found
No
The device description and performance studies focus on the physical properties and functionality of a standard epidural catheter, with no mention of AI or ML.
No
The device is described as an "epidural catheter" intended for the "administration of local anesthetics," which is a delivery method, not a treatment itself. It facilitates a therapeutic action but is not a therapeutic device on its own.
No
The device description indicates it is a catheter for administering local anesthetics, which is a therapeutic function, not a diagnostic one. There is no mention of it being used to gather information about a patient's condition.
No
The device description clearly outlines physical components like tubing, guides, connectors, and packaging, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "administration of local anesthetics into epidural space." This is a therapeutic procedure involving the delivery of a substance into the body.
- Device Description: The device is a catheter designed for insertion into the epidural space. It's a physical tool used for drug delivery.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are specifically designed to perform tests on samples like blood, urine, or tissue to diagnose or monitor medical conditions. This device's function is purely for delivering medication.
N/A
Intended Use / Indications for 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.
Product codes
BSO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All materials used in the fabrication of the epidural catheter were evaluated through biological qualification safety tests. The biocompatibility tests performed were: 1. Kligman Maximization Test 2. Intracutaneous Injection Test 3. Systemic Injection Test 4. Rabbit Pyrogen Test 5. L929 Mem Elution Test 6. Hemolysis Test 7. Subacute Toxicity. These materials have met the testing requirements and were found to be acceptable for the intended use. Busse Epidural Catheter has been tested for the following performance tests: 1. Liquid Leakage 2. Kink Test 3. Flow Rate 4. General Tensile Testing 5. Pull 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.
Micor Conduction Catheter, K001717
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
§ 868.5120 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).
0
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.
1
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
2
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.
3
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
4
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_