(52 days)
Not Found
Not Found
No
The summary describes a purely mechanical device for stabilizing skin and explicitly states "Not Found" for mentions of AI, DNN, or ML, and provides no information about training or test sets, which are typical for AI/ML devices.
No.
The device is used to stabilize skin during a procedure, not to treat a disease or condition.
No
The device is described as assisting in stabilizing the skin during a procedure, not in diagnosing a condition or disease. It performs a physical function rather than providing information about a patient's health status.
No
The device description explicitly states it is a "non-invasive two-pronged device," indicating a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to externally stabilize the skin over an implanted vascular access device during a needle removal procedure. This is a physical manipulation of the body's surface.
- Device Description: The device is described as a non-invasive two-pronged device used for stabilization. This aligns with a physical support or manipulation tool, not a device that analyzes biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any biological samples.
The device's function is purely mechanical and external, focusing on providing physical support during a medical procedure. This falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The tool is intended for use in assisting to externally stabilize the area of skin over the site of an implanted vascular access device, while a needle, which is implanted into the device, is removed from the device, manually, without direct contact between the user's hands and the intravascular access device site.
Product codes
80 LBJ
Device Description
The BPOS-IVAD STABILIZER is a non-invasive two-pronged device used to stabilize an area of the skin over an implanted vascular access device while performing a procedure on that immediate area.
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
No testing has been done.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.
0
K9834/80
NOV 2 3 1998
Summary 510(k)
BPOS-IVAD STABILLIZER
- DATE PREPARED 1. September, 1998
- SPONSOR INFORMATION: 2.
Bob Burns, Terry Shaffer, Jean Perlick Address: #7 Coralwind Aliso Viejo, CA 92656-1428
| Contact Person: | Ms. Terry Shaffer |
|---|---|
| Ph: (949) 455-9636 | |
| Fax: (949) 455-9636 |
BPOS-IVAD STABILIZER
510(k) Summary
Page 1
1
-
- DEVICE NAME:
· ,
- DEVICE NAME:
ਜ
BPOS-IVAD STABILIZER
Common Usual Name:
Grade/Proprietary Name:
Classification Name:
Vein Stabilizer
Implanted
Stabilizer
CFR 880.6980 Product Code 80 LBJ E Class I
Vascular
Access
Device
-
DEVICE DESCRIPTION AND INTENDED USE: 4.
The BPOS-IVAD STABILIZER is a non-invasive two-pronged device used to stabilize an area of the skin over an implanted vascular access device while performing a procedure on that immediate area. -
- PREDICATE DEVICE
The BPOS-IVAD STABILIZER is similar in design, function and intended use to a vein stabilizer. The vein stabilizer is a non-invasive two-pronged device that stabilizes an area of skin while performing a procedure on that immediate area.
- PREDICATE DEVICE
-
DEVICE TESTING 6.
No testing has been done.
Both devices utilize a plastic platform to stabilize the area while a procedure is performed on the immediate area between the prongs. Both devices are made of plastic. Both devices use hand pressure to the device to guide and provide leverage to assist in the procedure performed between the prongs. The anatomical site (needle insertion site) target patient and use populations (HCW) are the same for each device.
BSOD-IVAD STABILIZER September, 1998 Page 2 510(k) Summary
2
Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is black against a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 3 1998
Terry Shaffer, R.N. Principal BPOS, Incorporated #7 Coralwind Aliso Viejo, California 92656-1428
Re : K983480 BPOS-IVAD STABILIZER Trade Name: Requlatory Class: Unclassified Product Code: LJT October 2, 1998 Dated: Received: October 2, 1998
Dear Ms. Shaffer:
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 able beated in the 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, 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 inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 - Ms. Shaffer
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA deberined in four alence of your device to a legally rinding of babban device results in a classification for your marketca predicate and the 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 809.10 for in riguradiagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 ene regaranotification" (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 "http://www.fdal.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K983480 510(k)
BPOS-IVAD STABILIZER Device Name:
Indications for Use:
The tool is intended for use in assisting to externally stabilize the area of skin over the site of an implanted vascular access device, while a needle, which is implanted into the device, is removed from the device, manually, without direct contact between the user's hands and the intravascular access device site.
Concurrence of CDRN, Office of Device Evaluation (ODE)
Prescription Use Or (Per 21 CNR 801.109)
. ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ..............................................
Over-the-Counter Use
Patricia Crescenti
(Division Sign-Off)
( - Fision of Dental, Infection Control,
Division of Dental, Infection Control, and General Hospital, Infection
S100->>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>
Final Devices
510(k) Number K983480