(175 days)
UNKNOWN
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description is for a physical medical device (a catheter) without any mention of software or data processing capabilities.
No.
The device description states it is a Peripherally Inserted Central Catheter, which is typically used for drug delivery or fluid administration, not for treating a disease or condition itself.
No
Explanation: The "Intended Use" describes a medical procedure (peripheral intubation) and the "Device Description" identifies the product as a Peripherally Inserted Central Catheter, which is a medical instrument used for delivering substances, not for diagnosing conditions.
No
The device description explicitly states it is a "Peripherally Inserted Central 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 is for "peripheral intusio" (likely meaning infusion) when the patient's condition requires it. This describes a medical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is described as a "Peripherally Inserted Central Catheter." This is a medical device used to deliver fluids or medications directly into a patient's bloodstream.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to facilitate the delivery of substances into the body, which is a therapeutic or supportive intervention, not a diagnostic one.
N/A
Intended Use / Indications for Use
The indication for use is when the patient's condition requires the peripheral intusio
Product codes
80FOZ, 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 Peripherally Inserted Central Catheter.
The Peripherally Inserted Central Catheter is composed of materials that have been tested in accordance with and the ISO Standard 10993 for this category. The materials 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
Not Found
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 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
UNKNOWN
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
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
December 4, 1996
JUN - 2 1997
Mark S. Alsberge, Regulatory Affairs Manager Contact:
Product Name: Peripherally Inserted Central Catheter
Trade Name: Cavafix
Classification name:
Cardiovasular Class II, 80FOZ, 21 CFR 880.5200
SUBSTANTIAL EQUIVALENCE1 TO:
| 510(k) number | Name | Applicant |
|---|---|---|
| K861479 | Cavafix | B. Braun Medical Inc. |
| UNKNOWN | SoloPICC | SoloPak |
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 Peripherally Inserted Central Catheter.
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 Peripherally Inserted Central Catheter is composed of materials that have been tested in accordance with and the ISO Standard 10993 for this category. The materials have been determined to be suitable for the intended use of this product.
Substantial equivalence:
The Peripherally Inserted Central Catheter is similar in materials, form, and intended use to the Cavafix cleared by B. Braun Medical Inc. and the SoloPICC manufactured for SoloPak. There are no new issues of safety or effectiveness raised by Peripherally Inserted Central 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. Inside the circle is a stylized image of an abstract symbol, possibly representing human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark S. Alsberge Manager, Regulatory Affairs B. Braun Medical, Inc. 824 12th Avenue Bethlehem, Pennsylvania 18018
JUN - 2 1997
K964929 Re: Trade Name: ACCUGUIDE® Multilumen Catheter Regulatory Class: Unclassified Product Code: LJS Dated: March 25, 1997 Received: March 28, 1997
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 of Act. However, you are responsible to determine that the 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.q., 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 reqistration, 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 regulations 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) requlation (21 CFR Part 820) and that, through periodic GMP
3
Page 2 - Mr. Alsberge
inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your 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.
In addition, we have determined that your device kit contains the following which are subject to regulation as drugs:
- 米 alcohol swabsticks,
-
- Povidone-Iodine swabsticks,
-
- 10 ml. ampul, 0.9% NaCl,
-
- skin protectant prep pad,
- Teqaderm™ dressing, and メ
- ★ 5 ml. ampul of Lidocaine HCl, 1%.
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 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 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket
4
Page 3 – Mr. Alsberge
notification" (21 CFR 807.97). Other general information on nocircation (2) of oth ooder the Act, may be obtained from the your responsibilities andor ors Assistance at its toll free Division Or Smarr HanaraCtarers (301) 443-6597, or at its internet address "dsmo@fdadr.cdrh.fda.goy".
Sincerely yours,
Alatorre
Timothy A Ulatowski 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):
11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
Device Name: Peripherally Inserted Central Catheter Indications For Use:
The indication for use is when the patient's condition requires the peripheral intusio
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
:
(Division Sign-Off) Division of Cardiovascu and Neurological Devi 510(k) Numbe
OR
Over-The-Counter Use
(Optional Format 1-2-96)