(198 days)
For the administration of anesthetic agents into the epidural space. B. Braun recommends that the epidural catheter be removed or replaced every 72 hours.
B. Braun Medical Inc. intends to introduce into interstate commerce the Soft Tip Epidural Catheter Kit. These have the same design, components, and performance characteristics as the catheters currently marketed by B. Braun Medical and covered under K813186 for the Perifix Set. The intended use is for the repeated administration of anesthetic agents into the epidural space. The only difference is the soft tip of the catheter. Soft tip epidural catheters are less traumatic and reduce the incidence of catheter induced paresthesias.
The provided text is a 510(k) summary for a medical device (Soft Tip Epidural Catheter Kit) seeking substantial equivalence to existing devices. It does not describe a study involving acceptance criteria and device performance in the context of AI or diagnostic algorithms. Instead, it focuses on demonstrating that the new device is as safe and effective as previously cleared predicate devices through material equivalence, design similarity, and standard quality control testing for manufacturing release.
Therefore, I cannot provide the requested information about acceptance criteria for device performance, especially those related to AI model evaluation, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The document discusses:
- Device Description: The Soft Tip Epidural Catheter Kit has the same design, components, and performance characteristics as the predicate device (Perifix Set - K813186) with the only difference being a "soft tip" which is claimed to be less traumatic and reduce catheter-induced paresthesias. It also references another predicate (Arrow's Flex Tip Plus - K801912).
- Material Biocompatibility: B. Braun Medical certifies that biocompatibility tests, as recommended in Tripartite Guidance, will be completed for all materials.
- Safety and Effectiveness: "All finished products are tested and must meet all required release specifications before distribution." These tests include sterility, pyrogenicity, physical testing, and visual examination. Physical testing is defined by Quality Control Test Procedure documents that conform to product design specifications.
- Intended Use: For the repeated administration of anesthetic agents into the epidural space.
The document does not contain information about:
- Specific acceptance criteria for device performance beyond general "required release specifications" or "product design specifications."
- A study proving the device meets these criteria in terms of clinical outcomes or comparative performance against a predefined benchmark, other than demonstrating substantial equivalence to predicates.
- Any details about AI or diagnostic algorithms.
- Sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
- Training set information.
In summary, the provided text is a regulatory submission for substantial equivalence based on manufacturing and material similarity to predicate devices, not a study evaluating performance against specific acceptance criteria for AI or diagnostic effectiveness.
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March 31, 1997
II 510 (k) Summary
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610) 691-5400
Regulatory Affairs Director Mark S. Alsberge, CONTACT :
PRODUCT NAME: Soft Tip Epidural Catheter Kit
TRADE NAME: Anesthetic Conduction Kit
CLASSIFICATION NAME:
Anesthesiology Class II, 73 CAZ, Anesthetic Conduction Kit 21 CFR 868.5140
SUBSTANTIAL EQUIVALENCE TO:
| 510 (k) number | Name | Applicant |
|---|---|---|
| K813186 | Perifix Set | B. Braun Medical, Inc. |
| K801912 | Positive PlacementContinuous Epidural | Arrow International,Inc. |
DEVICE DESCRIPTION:
B. Braun Medical Inc. intends to introduce into interstate commerce the Soft Tip Epidural Catheter Kit. These have the same design, components, and performance characteristics as the catheters currently marketed by B. Braun Medical and covered under K813186 for the Perifix Set. The intended use is for the repeated administration of anesthetic agents into the epidural space. The only difference is the soft tip of the catheter. Soft tip epidural catheters are less traumatic and reduce the incidence of catheter induced paresthesias. Arrow currently markets a Flex Tip Plus epidural catheter which we believe to be covered under K801912.
- The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act and relates
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to the fact that the product can be marketed without premarket approval or reclassification. Such a determination is not intended to be applicable to patent infringement suits or any other patent matter related to this product or the technology used to manufacture the product.
MATERIAL:
B. Braun Medical certifies that the biocompatibilty tests recommended in the Tripartite Guidance for this category of contact duration will be completed for all the materials used in the manufacture of the device.
SUBSTANTIAL EQUIVALENCE:
The Soft Tip Epidural Catheters Kits are equivalent in materials, form, and intended use to the Perifix Sets currently marketed by B. Braun, Inc., covered under K813186. They are also similar to Arrow's Flex Tip Catheter which we believed to be covered under K801912. The kit components are identical to those items which were offered in the Perifix Kit. There are no new issues of safety or effectiveness raised by the Soft Tip Epidural Catheters.
SAFETY AND EFFECTIVENESS:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; sterility, pyrogenicity (endotoxin/ LAL Method), physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually required procedures are approved, released, distributed and revised in accordance with document control GMP"s.
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III Proposed Labeling
- a) Device and Package labels:
A draft sample label for the Soft tip epidural Catheter kit is included in Attachment 1.
b) Manuals and Package Insert:
No additional package insert is planned at this time. A manual is not applicable to this device.
-
c) Statement of Intended Use:
The soft tip epidural Catheters are intended for the repeated administration of anesthetic agents into the epidural space. -
d) Advertisements or Promotional Materials:
No advertisements or promotional materials have been prepared at this time.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
APR - 4 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark S. Alsberge B. Braun Medical Incorporated 824 Twelfth Avenue P.O. Box 4027 Bethlehem, Pennsylvania 18018-0027
Re: K971233
Trade/Device Name: Soft Tip Epidural Catheter Kit Regulation Number: 868.5140 Regulation Name: Anesthesia conduction kit Regulatory Class: II Product Code: CAZ Dated: July 16, 1997 Received: July 21, 1997
Dear Mr. Alsberge:
This letter corrects our substantially equivalent letter of October 17, 1997.
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 (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 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. Alsberge
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue 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/dsma/dsmamain.html
Sincerely yours,
Smylie Y. Michaux Oms.
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Soft Tip Epidural Catheter Kit Device Name:_
.
:
Indications For Use:
."
:
For the administration of anesthetic agents into the epidural space. B. Braun recommends that the epidural catheter be removed or replaced every 72 hours.
(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 | Anesthesiology, General Hospital, |
| Infection | |
| 510(k) Number | K971233 |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
|---|---|
| --------------------------------------- | ------------------------- |
(Optional Forrazi 1-2-96)
§ 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).