(173 days)
Not Found
No
The description focuses on the mechanical aspects of securing a probe and mentions no software, algorithms, or data processing that would suggest AI/ML.
No
The device is a fixation device intended to secure a probe or catheter to the patient's skin, which is a supportive rather than a therapeutic function. Its purpose is to hold another device (QFlow Perfusion Probe) in place, not to directly treat or diagnose a medical condition.
No
The device is a fixation device for securing a probe to the skin, not a device that diagnoses a condition or disease. It is used in conjunction with a probe (QFlow Perfusion Probe) which may be diagnostic, but the Hemedex Fixation Device itself is not.
No
The device description explicitly states it is a "compact soft silicone disk with a securing clamp and adhesive dressing," which are physical hardware components.
Based on the provided information, the Hemedex Fixation Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to secure a probe to the patient's skin. This is a physical function performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a physical device for securing something to the skin. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, urine, tissue, etc.), performing tests, or providing diagnostic information based on the analysis of biological material.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Hemedex Fixation Device does not fit this description.
N/A
Intended Use / Indications for Use
The Hemedex Fixation Device is intended to be used on the patient's skin to secure the percutaneous placement of the QFlow Perfusion Probe.
Product codes
78 KNY, 78 FGE, 74 DPW, 74 DPT
Device Description
The Hemedex Fixation Device is a compact soft silicone disk with a securing clamp and adhesive dressing for securing a probe or catheter to the patients skin. The clear pressure sensitive adhesive dressing allows for easy visual inspection of catheter entry site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
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
Bench testing was conducted to demonstrate that this device meets the requirements of its intended use and meets the specified performance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized human profiles or birds in flight, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2004
Hemedex, Inc. c/o Ms. Debbie Iampietro President, QRC Consulting 7 Tiffany Trail HOPKINTON MA 01748
Re: K032127
Trade/Device Name: Hemedex Fixation Device Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Product Code: 78 KNY Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Product Code: 78 FGE Regulation Number: 21 CFR §870.2100 Regulation Name: Cardiovascular blood flow meter Regulatory Class: 74 DPW Regulation Number: 21 CFR §870.2120 Regulation Name: Extravascular blood flow probe Product Code: 74 DPT Regulatory Class: II Dated: October 2, 2003 Received: October 3, 2003
Dear Ms. Iampietro:
This letter corrects our substantially equivalent letter of December 30, 2003, regarding the Hemedex Fixation Device. One of the product codes was originally listed as 78 K YN, but should have been listed as 78 KNY.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent [{for the indications for use stated in the enclosure)] to legally marketed predicate 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) that do not require approval of a premarket approval (PMA). 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.
1
Page 2 - Ms. Debbie Iampietro
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Zavid 6. kf:vde.
Nancy C. Brogdon 91 Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Hemedex, Inc Fixation Device Premarket Notification
KO32127 510(k) Number (if known):
Devicc Name: Fixation Device
Indications For Use:
The Hemedex Fixation Device is intended to be used on the patient's skin to secure the percutaneous placement of the QFlow Perfusion Probe.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use L (Per 21 CFR 801.109)
ાર
Over-The-Counter Use
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number
Page 13 of 35
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Hemedex, Inc Fixation Device Premarket Notification
1032127
510K Summary of Safety and Effectiveness
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Sponsor Name 1.
Hemedex, Inc. 222 Third Street, Suite T123 Cambridge, MA 02142 USA -
- Device Name QFlow 500 Probe Fixation Disk
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Identification of Predicate or Legally Marketed Device 3. UreSil Fixation Device (K914699)
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- Device Description
The Hemedex Fixation Device is a compact soft silicone disk with a securing clamp and adhesive dressing for securing a probe or catheter to the patients skin. The clear pressure sensitive adhesive dressing allows for easy visual inspection of catheter entry site.
5. Intended Use
The Hemedex Fixation Device is intended to be used on the patient's skin to secure the percutaneous placement of the QFlow Perfusion Probe
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- Comparison of Technological Characteristics
This device is the exact same device as that marketed by UreSil under K914699 except the diameter has been reduced to accommodate the QFlow Probe OD. The materials are the same as that in K914699. In fact UreSil is the manufacturer of the Hemedex Fixation device.
- Comparison of Technological Characteristics
7 Performance Testing
Bench testing was conducted to demonstrate that this device meets the requirements of its intended use and meets the specified performance criteria.