(69 days)
K834473A
Not Found
No
The document describes a physical medical device (catheter) and its intended use for administering fluids. There is no mention of software, algorithms, or any terms related to AI/ML. The performance studies described are standard physical and visual testing for a medical device.
Yes
The device, a Soft Tip Multi-Lumen Catheter, is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids, or drugs. These applications are for medical treatment or support, which falls under the definition of a therapeutic device.
No
The device is described as being for "administration of blood products, parenteral nutrition, I.V. fluids or drugs," which indicates a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is a "Soft Tip Multi- Lumen Central Venous Catheter," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs." This describes a device used in vivo (within the body) for therapeutic or supportive purposes.
- Device Description: The description reiterates the same intended use, emphasizing insertion into the venous system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs are used outside the body to analyze these specimens.
Therefore, the Soft Tip Multi-Lumen Catheter, as described, is a medical device used for direct patient care and administration of substances into the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The soft Tip Multi-Lumen Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition ;- I.V. fluids or drugs.
Product codes
LJS
Device Description
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Soft Tip Multi- Lumen Central Venous Catheter . A Soft Tip Multi- Lumen Central Venous Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs.
Material:
The Soft Tlp Multi-Lumen Central Venous Catheter is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous system
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
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; 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.
Key Metrics
Not Found
Predicate Device(s)
K834473A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
II 510(k) Summary of Safety and Effectiveness In Accordance with SMDA'90
K971085
June 2, 1997
March 7, 1997
B. Braun Medical, Inc 824 Twelfth Avenue Bethiehem, PA 18018 (610)691-5400
| Contact: | Mark S. Alsberge, Regulatory Affairs Manager |
|---|---|
| Product Name: | Soft Tip Multi-Lumen Central Venous Catheter |
| Trade Name: | Catheter, Percutaneous Intravascular, Long term |
Classification name:
Hospital Unclassified, 80LJS 21 CFR
SUBSTANTIAL EQUIVALENCE' TO:
| K834473A | Accuguide Multi-Lumen
Central Venous Catheter Kit | B. Braun Medical Inc. |
| ---------- | ------------------------------------------------------ | ----------------------- |
|---|
Device Description:
In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce a Soft Tip Multi- Lumen Central Venous Catheter . A Soft Tip Multi- Lumen Central Venous Catheter is a device that is inserted into the venous system for the administration of blood products, parenteral nutrition, I.V. fluids or drugs.
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.
1
Material:
The Soft Tlp Multi-Lumen Central Venous Catheter is composed of materials that have been tested in accordance with the ISO Standard 10993 and have been determined to be suitable for the intended use of this product.
Substantial equivalence:
The Soft Tip Multi-Lumen Central Venous Catheter is similar in materials, form, and intended use to the Accuguide Multi-Lumen Central Venous Catheter Kit cleared by B. Braun Medical Inc. There are no new issues of safety or effectiveness raised by The Soft Tip Multi-Lumen Central Venous Catheter.
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; 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.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Mark S. Alsberge Manager, Regulatory Affairs B. Braun Medical, Incorporated 824 Twelfth Avenue Bethlehem, Pennsylvania 18018
JUN - 2 1997
K971085 Re : Soft Tip Multi-Lumen Central Venous Trade Name: Catheter Unclassified Regulatory Class: Product Code: LJS Dated: March 11, 1997 March 25, 1997 Received:
Dear Mr. Alsberge:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market the device, subject to the general controls provisions However, you are responsible to determine that the of Act. medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. 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 (Premarket Approval) it may be subject to additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP)
3
Page 2 - Mr. Alsberge
解: 详!!
regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization process used for the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:
- The labeling, packaging and method of sterilization of 1. the suture cannot be changed without prior notification, review and clearance by FDA.
- The supplier of the sutures used in your device cannot be 2. changed without prior notification, review and clearance by FDA.
In addition, we have determined that your device kit contains a 5 ml. ampul of lidocaine and povidone iodine ointment which are subject to regulation as drugs.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0063
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
4
Page 3 - Mr. Alsberge
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 requlation (21 CFR Part 801 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) Additionally, for questions on the promotion and 594-4618. advertising of your device, please contact the Office of Compliance Also, please note the regulation entitled, at (301) 594-4639. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041/for at (301) 443-6597.
Sincerely yours,
Tim K. R. Wlatowski
Tim Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| 510(k) Number (if known): | K971085 |
|---|---|
| Device Name: | Soft Tip Multi-Lumen Central Venous Catheter |
| Indications For Use: | The soft Tip Multi-Lumen Catheter |
| is a device that is inserted into | |
| the venous system for the administration | |
| of blood products, parenteral nutrition ;- | |
| I.V. fluids or drugs. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Compliance of CDRH, Office of Device Evaluation (ODE)
| (Division | Patrician Conti |
|---|---|
| Division of | Infection Control, |
| and General Hospital Devices | |
| 510(k) Number | K971085 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
: : : :