The ComCaSet-P Safety IV Catheter is indicated to sample blood, monitor blood pressure, or administer fluids intravenously. The ComCaSet-P 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-P 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 When the catheter hub and needle assembly components are withdrawn, the shielding mechanism is activated and the needle retracts into the shielding tube.

Device Description

The ComCaSet-P 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-P Safety IV Catheter has a safety locking mechanism which enables the needle and the flash chamber to retract into a safety barrel. Disconnecting the needle assembly and catheter hub from the catheter releases the latex-free elastic rubber band and allows the needle and flash chamber to retract quickly into the safety barrel.

AI/ML Overview

The provided text, K070020 for the ComCaSet-P Safety IV Catheter, is a 510(k) summary. A 510(k) submission generally focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical studies with acceptance criteria, sample sizes, and ground truth methodologies like those found in PMA applications or more recent AI/ML device clearances.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth for the training set was established.

This 510(k) submission primarily relies on demonstrating that the ComCaSet-P Safety IV Cather is substantially equivalent to a previously cleared predicate device (ComCaSet Safety IV Catheter, K062108). The safety and effectiveness are inferred from the predicate device through direct comparison of features and intended use.

Based on the provided text, the following information can be extracted or explicitly stated as not available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of acceptance criteria or performance metrics derived from a specific study designed to meet such criteria. The "performance" described is largely a functional description and equivalence to the predicate.

Implied Performance: The primary "performance" characteristic highlighted is the safety locking mechanism for reducing accidental needle sticks, but no quantitative acceptance criteria or study results are presented for this.

Functional Specifications (from Device Description): The document provides specifications for catheter gauges, dimensions, and water flow rates. These are descriptive rather than criteria for a study demonstrating efficacy or safety beyond substantial equivalence.

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

Note: These are product specifications, not "reported device performance" in the context of a clinical study proving acceptance criteria for safety or efficacy.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable / Not Provided: This device is a traditional medical device (IV Angiocatheter), not an AI/ML device. The 510(k) submission relies on substantial equivalence to a predicate, not on a clinical "test set" in the context of an AI/ML algorithm evaluation. No specific clinical study with a defined test set sample size or data provenance is mentioned in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not Applicable / Not Provided: See point 2. Ground truth establishment by experts is not described for this type of device submission.

4. Adjudication Method for the Test Set:

Not Applicable / Not Provided: See point 2. No adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size:

No: The document does not describe an MRMC comparative effectiveness study. This type of study is generally conducted for interpretive devices, especially those incorporating AI, to assess reader performance with and without AI assistance. The ComCaSet-P Safety IV Catheter is a physical, invasive medical device for fluid administration/blood sampling, not an interpretive device.

6. If a Standalone Performance Study Was Done:

No: The document does not describe a standalone performance study. The evaluation primarily focuses on the device's design, materials, and functional equivalence to a predicate, particularly its safety mechanism.

7. The Type of Ground Truth Used:

Not Applicable / Not Provided: For this type of device, ground truth as typically understood for AI/ML or diagnostic devices (e.g., pathology, outcomes data, expert consensus) is not applied. Substantial equivalence relies on comparing the new device's characteristics and intended use to a legally marketed predicate device.

8. The Sample Size for the Training Set:

Not Applicable / Not Provided: This is not an AI/ML device that requires training data.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable / Not Provided: See point 8.

Summary of the 510(k) Approach for ComCaSet-P Safety IV Catheter:

The submission demonstrates substantial equivalence by stating:

The ComCaSet-P Safety IV Catheter has the same intended use as the predicate device (ComCaSet Safety IV Catheter, K062108).
It has the same principle of operation.
The main technological difference is the release element of the needle retraction element, which in the ComCaSet-P is activated by the separation of the catheter hub and needle assembly from the catheter. This modification is presented as a design change without raising new safety or effectiveness concerns, implying that the predicate's established safety and effectiveness extend to the modified device.

The FDA's decision letter (K070020) confirms that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to proceed to market under general controls.

Summary

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K070020

1 of 3

Pitango Medical Ltd.

510(k) Summary:

ComCaSet-P Safety IV Catheter

AUG 1 6 2007

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: December 27, 2006

Trade Name: ComCaSet-P Safety IV Catheter.

Classification name: Intravascular catheter

Class: II

Panel identification: General Hospital Devices

Product code: FOZ

Regulation number: 880.5200

Predicate Device: ComCaSet Safety IV Catheter, Pitango Medical Ltd, Ramat Gan, Israel, cleared under 510(k) no. 062108.

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Pitango Medical Ltd.

Device description:

Disconnecting the needle assembly and catheter hub from the catheter releases the latex-free elastic rubber band and allows the needle and flash chamber to retract quickly into the safety barrel.

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:

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Pitango Medical Ltd.

Substantial Equivalence:

The ComCaSet Safety-P IV Catheter has the same intended use and the same principle of operation as the ComCaSet Safety IV Catheter cleared under 510(k) no. K062108. The main technological difference between ComCaSet-P Safety IV Catheter and the predicate devices is the release element of the needle retraction element, which at the ComCaSet-P Safety IV Catheter is activated by the separation of the catheter hub and needle assembly from the catheter.

Conclusion:

The evaluation of the ComCaSet-P 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 & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized image of an eagle. The eagle is depicted with three lines forming its body and wings, suggesting movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ben Levin Managing Director Pitango Medical Limited 3A Jabotinski Street, 28th Floor Diamond House-Doron Levy Ramat Gan, Israel 52520

AUG 16 2007

Re: K070020

Trade/Device Name: ComCaSet-P Safety IV Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: July 31, 2007 Received: August 6, 2007

Dear Mr. Levin:

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 - Mr. Levin

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 vour 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.

Clus

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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Korodo

Indications for Use

510(k) Number (if known): _ KO 70020

Device Name: ComCaSet-P Safety IV Catheter

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qhuls

mon Sign-Off) rsion of Anesthesiology, General Hospital Inrection Control, Dental Devices

umber. K070020

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).