HEMEDEX FIXATION DEVICE by HEMEDEX INCORPORATED

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.

AI/ML Overview

I am sorry, but based on the provided text, there is no detailed information available regarding acceptance criteria, device performance metrics, or the actual study results that would allow me to populate the requested table and answer questions 2 through 9.

The document is a 510(k) premarket notification letter from the FDA to Hemedex, Inc. for their Fixation Device. It primarily states that the device has been found substantially equivalent to a predicate device (UreSil Fixation Device K914699).

Here's what the document does state in relation to performance testing:

Section 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."

However, this statement provides no specifics about:

What those "specified performance criteria" were.
The actual results of the "bench testing."
The methodology, sample sizes, or ground truth establishment for any such testing.

Therefore, I cannot provide the requested information. The document only confirms that some bench testing was done to demonstrate the device meets its intended use and performance criteria, but it does not elaborate on these aspects in any way that fulfills the detailed questions asked.

Summary

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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.

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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

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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)

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Over-The-Counter Use

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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Hemedex, Inc Fixation Device Premarket Notification

1032127

510K Summary of Safety and Effectiveness

Sponsor Name 1.
Hemedex, Inc. 222 Third Street, Suite T123 Cambridge, MA 02142 USA
1. Device Name QFlow 500 Probe Fixation Disk
Identification of Predicate or Legally Marketed Device 3. UreSil Fixation Device (K914699)
1. Device Description

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

1. 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.

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.

Regulation Number and Section

§ 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.