The ComCaSet Safety IV Catheter is indicated to sample blood, monitor blood pressure, or administer fluids intravenously. The ComCaSet Safety IV Catheter may be used for any patient population with consideration given to adequacy of the vascular anatomy appropriateness for the solution being administered and duration of the therapy. The ComCaSet Safety IV Catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the catheter hub and needle assembly components are withdrawn, the user activates the shielding mechanism and the needle retracts into the shielding tube.

Device Description

The ComCaSet Safety IV Catheter consists of several parts common to most IV catheters: stainless steel needle. Teflon catheter tube with hub and the catheter body. In addition, the ComCaSet Safety IV Catheter has a safety locking mechanism which, when activated, enables the needle and the flash chamber to retract into a safety barrel. The activation element holds the needle assembly in the forward position until the user activates the device. Pulling the activator releases the latexfree elastic rubber band and allows the needle and flash chamber to retract quickly into the safety barrel. In this way user maintains control of the process by determining when to activate the safety mechanism. The product is available in seven gauges identified also by specific colors.

AI/ML Overview

The provided text is a 510(k) summary for the ComCaSet Safety IV Catheter. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting detailed clinical study results with specific acceptance criteria and performance metrics of the new device itself.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets those criteria in the way you've outlined for performance metrics such as sensitivity, specificity, or accuracy. This submission focuses on comparing the new device against a legally marketed predicate device (Insyte™ Autoguard™ Shielded IV Catheter) to establish that it is substantially equivalent in terms of intended use, principle of operation, and safety/effectiveness.

Here's what can be extracted from the document based on your request, with an emphasis on what is not present:

1. A table of acceptance criteria and the reported device performance

Not provided. The document does not define specific performance acceptance criteria for its safety features (e.g., minimum retraction rate, maximum force to activate) or general catheter performance (e.g., flow rate accuracy, material bio-compatibility under specific conditions). Instead, it relies on the established safety and effectiveness of the predicate device.
The table presented in the device description section is for the physical specifications and flow rates of different gauges of the catheter, not performance data from a specific study against acceptance criteria.

Size	Color	Catheter I.D. mm	Catheter O.D. mm	Catheter Length (mm)	Water Flow Rate (ml./min.)
14G	Orange	1.7	2.1	45	270
16G	Grey	1.3	1.7	45	180
17G	White	1.1	1.5	45	125
18G	Green	0.9	1.3	45	80
20G	Pink	0.8	1.1	32	54
22G	Blue	0.6	0.9	25	33
24G	Yellow	0.5	0.7	19	20

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not applicable/Not reported. The document does not describe a performance study with a "test set" in the context of AI/diagnostic device validation. It's a medical device submission focused on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable/Not reported. This information is not relevant to a 510(k) submission for a non-diagnostic medical device like an IV catheter.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/Not reported. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI/diagnostic device, and no MRMC study is mentioned or relevant to this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not reported. The "ground truth" for this type of device typically refers to engineering performance specifications and material biocompatibility, which are not detailed in this summary. The submission's "truth" is its substantial equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not applicable/Not reported. This is not an AI/machine learning device; there is no "training set."

9. How the ground truth for the training set was established

Not applicable/Not reported. See point 8.

Summary of Device Comparison for Substantial Equivalence:

The core of this 510(k) summary is the claim of substantial equivalence to the predicate device:

Predicate Device: Insyte™ Autoguard™ Shielded IV Catheter from Becton-Dickinson Infusion Therapy Systems Inc (K984059).
Intended Use: Same – "to sample blood, monitor blood pressure, or administer fluids intravenously." Also includes a shielding mechanism to reduce accidental needle sticks.
Principle of Operation: Same, both are IV catheters with a safety locking mechanism that retracts the needle.
Technological Difference: The main difference is the release element for the needle retraction:
- ComCaSet Safety IV Catheter: latex-free elastic rubber band
- Predicate Device: spring
Conclusion: The document asserts that this technological difference "does not raise any additional concerns regarding safety and effectiveness" and therefore the device is substantially equivalent to the predicate.

In essence, the "study" mentioned implicitly is the comparison of the new device's design, materials, and intended use against the legally marketed predicate, concluding that the differences do not alter the safety or effectiveness profile significantly enough to warrant a more extensive premarket approval process.

Summary

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Kp62148 (P.10^3)

Pitango Medical Ltd.

510(k) Summary:

AUG - 8 2006

ComCaSet Safety IV Catheter

Company Name:

Pitango Medical Ltd. Ltd.

Contact Person: Ben Levin Managing Director Telephone: +972-3-613-0480 +972-3-613-0481 Fax: E-mail: belevin@pitangomedical.com

Authorized US Agent:

George J. Hattub, RAC & CQE Senior Staff Consultant MedicSense Inc. 291 Hillside Avenue Somerset, Massachusetts 02726

Phone: (508) 479-6116 (508) 677-1418 Fax: E-Mail: george@medicsense.com

Date prepared: May 25, 2006

Trade Name: ComCaSet Safety IV Catheter

Classification name: Intravascular catheter

Class: II

Panel identification: General Hospital Devices

Product code: FOZ

Regulation number: 880.5200

Predicate Devices: Insyte™ Autoguard™ Shielded IV Catheter form Becton-Dickinson Infusion Therapy Systems Inc in Sandy, Utah, cleared under 510(k) no. K984059

{1}------------------------------------------------

K462198 (p.2aA3)

Pitango Medical Ltd.

Device description:

The activation element holds the needle assembly in the forward position until the user activates the device. Pulling the activator releases the latexfree elastic rubber band and allows the needle and flash chamber to retract quickly into the safety barrel. In this way user maintains control of the process by determining when to activate the safety mechanism.

The product is available in seven gauges identified also by specific colors as follows:

Size	Color	Catheter		CatheterLength(mm)	WaterFlow Rate(ml./min.)
		I.D.mm	O.D.mm
14G	Orange	1.7	2.1	45	270
16G	Grey	1.3	1.7	45	180
17G	White	1.1	1.5	45	125
18G	Green	0.9	1.3	45	80
20G	Pink	0.8	1.1	32	54
22G	Blue	0.6	0.9	25	33
24G	Yellow	0.5	0.7	19	20

Indications for Use:

{2}------------------------------------------------

K462148 (P.3 of 3) Pitango Medical Ltd.

Substantial Equivalence:

The ComCaSet Safety IV Catheter has the same intended use and the same principle of operation as the Insyte " Autoguard " Shielded IV Catheter form Becton-Dickinson Infusion Therapy Systems Inc in Sandy, Utah, cleared under 510(k) no. K984059. The main technological difference between ComCaSet Safety IV Catheter and the predicate devices is the release element of the needle retraction element, which at the ComCaSet Safety IV Catheter consists of a latex-free elastic rubber band and at the predicate device consists of a spring.

Conclusion:

The evaluation of the ComCaSet Safety IV Catheter does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (USA). The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 8 2006

Pitango Medical Limited C/O Ms. Patricia L. Murphy Responsible Third Party Official Kema Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914

Re: K062108

Trade/Device Name: ComCaSet Safety IV Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: July 18, 2006 Received: July 24, 2006

Dear Ms. Murphy:

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 application (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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Murphy

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 (QS) 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 begin 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/industry/support/index.html.

Sincerely yours,

State of Michigan Oms

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K 462138 510(k) Number (if known): _

Device Name: ComCaSet Safety IV Catheter

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cutter is n

on of Anesthesiology, General Hospital, Jon Control. Dental Devices

) Number: 5962198
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Page 1 of 1

Regulation Number and Section

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).