(77 days)
Not Found
No
The summary describes a device that aids in catheter placement using the RAECG technique, which is a known method utilizing electrical signals. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The predicate device also appears to be a non-AI/ML device.
No
A therapeutic device is one that treats, cures, or prevents disease. This device aids in the accurate placement of central venous catheters, which is a diagnostic or procedural aid, not a therapeutic action itself.
No
Explanation: The device is described as an adapter designed to aid in the accurate placement of central venous catheters using the RAECG technique. Its function is to assist in a medical procedure (placement of catheters), not to diagnose a disease or condition. While it uses ECG, it's for guidance during placement, not for diagnostic interpretation of cardiac activity.
No
The device description refers to an "Adapter," which implies a physical hardware component used in conjunction with the RAECG technique. The summary does not explicitly state it is software-only.
Based on the provided information, this device is likely not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in the accurate placement of central Venous catheters using the RAECG technique." This describes a procedure performed on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is an "Adapter designed to aid in the accurate placement of central venous catheters using the RAECG technique." This further reinforces its role in a medical procedure, not a diagnostic test on a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
In summary, the device's function is to assist in a medical procedure (catheter placement) using a physiological signal (ECG), not to perform a diagnostic test on a biological sample. Therefore, it falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
in the accurate placement of central aid ﺍﻟﻤ catheters using the RAECG technique Venous
Product codes
DQY
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 the Certodyn® RAECG Universal Adapter. The Adapter is designed to aid in the accurate placement of central venous catheters using the RAECG technique. The Certodyn® RAECG Universal Adapter is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and 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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
NOV 2 4 1997
II. 510(k) SUMMARY of SAFETY and EFFECTIVENESS in ACCORDANCE with SMDA'90
B. Braun Medical, Inc 1997 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
Contact: Mark S. Alsberge, Regulatory Affairs Director
Product Name: Epidural Catheter Connector
Trade Name: Conduction Anesthesia Kit
Classification Name:
Cardiovascular Class II, 74 DQY, Percutaneous Catheter 21 CFR 870.1250
Substantial Equivalence to:
| 510(k) number | Name | Applicant |
|---|---|---|
| K843263 | Arrow-Johans ECG Adaptor | Arrow International, 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 the Certodyn® RAECG Universal Adapter. The Adapter is designed to aid in the accurate placement of central venous catheters using the RAECG technique.
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
Materials:
The Certodyn® RAECG Universal Adapter is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.
Substantial Equivalence:
The Certodyn® RAECG Universal Adapter is equivalent in materials, form, and intended use to our the Arrow-Johans ECG Adaptor currently marketed under K843263 by Arrow International, Inc. There are no new issues of safety or effectiveness raised by the Certodyn® RAECG Universal Adapter.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
NOV 2 4 1997
Mr.. Mark S. Alsberge Director, Regulatory Affairs B. Braun Medical, Inc. 824 12th Avenue Bethlehem, PA 18018-0027
Re: K973371 Trade Name: Certodyn RAECG Universal Adapter Regulatory Class: II ... Product Code: DOY Dated: September 3, 1997 Received: September 8, 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 (Act). 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 (Premarket Approval), it may be subject to such 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) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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.
3
Page 2 - Mr. Mark S. Alsberge
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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "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 or (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.gov".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
- K923321 - -510(k) Number (if known):
Device Name: Certody n RAEC G Universal Adapter
Indications For Use:
in the accurate placement of central aid ﺍﻟﻤ catheters using the RAECG technique Venous
(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 of Cardiovascular,
and Neurological Devices
510(k) Number K973371
Prescription Use X
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)