(734 days)
Not Found
Not Found
No
The summary provides no information about the device's technology, and specifically states that AI, DNN, or ML are not mentioned.
Yes
The device creates an atrial septal defect, which is a medical intervention intended to treat or manage a condition, thereby qualifying it as therapeutic.
No
The intended use is to create an atrial septal defect and provide transseptal left heart access, which are interventional procedures, not diagnostic ones.
No
The intended use describes a physical intervention (creating an atrial septal defect) which strongly suggests a hardware component is involved, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "create an atrial septal defect in the heart" and for "Transseptal left heart access." This describes a surgical or interventional procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside the body (in vitro).
The description clearly indicates a device used inside the body for a therapeutic or procedural purpose, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
To create an atrial septal defect in the heart. Transseptal left heart access.
Product codes
DXF
Device Description
Baylis Medical RF Septostomy System
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.5175 Septostomy catheter.
(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing shapes, creating a sense of depth and movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB = 1 2001
Mr. Kris Shah Baylis Medical Co., Inc. 5160 Explorer Drive, Unit 33 Mississauga, Ontario, Canada L4W 4T7
K990284 Re:
Trade Name: Baylis Medical RF Septostomy System Regulatory Class: II (two) Product Code: DXF Dated: November 15, 2000 Received: November 16, 2000
Dear Mr. Shah:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section 5 ro(x) notification of equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstant commerce stated in the enclosure) to legally manacted processor of the Medical Device American of the American Commend pror to May 20, 1910, the chareas with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act). " Fournal), and controls provisions of the Act include requirements for provisions of the Act. "The general control contracturing 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 (Fremarket Applovar), it may of below of Federal Regulations, Title 21, Parts 800 to allecting your device can or reacle ermination assumes compliance with the Current Good 897. A substainmally oqui rains as set forth in the Quality System Regulation (QS) for Manufacturing Fractice requiration (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mispections, the rood and Drug Hammesult in regulatory action. In addition, FDA may publish comply with the GHT Togation in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might response to your premarter nouts 42 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Kris Shah
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) 594-4586. Additionally, for questions on the promotion and advertising of your device, (201) 594-156. Tracklent Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 ".http://www.fda.gov/cdrh/dsmain.html".
Sincerely yours,
Stam Katerpus
James E. Dillard MI Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1__of_1
510(k) Number (if known): K990284
Device Name: Baylis Medical RF Septostomy System
Indications For Use:
To create an atrial septal defect in the heart. Transseptal left heart access.
(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)
OR
Over-The-Counter Use" .
(Optional Format 1-2-96)
Stuse Portocarrero 2-1-1
Division of Cardiovascular & Respiratory Devices
510(k) Number K990284