The STD Med Primo Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I. V. fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.

Device Description

The STD Med Primo Port kit contains 1 Titanium port, 1 catheter of choice, and 2 corresponding catheter locks, The catheter is introduced into the vascular system and attached to the port stem using a catheter lock. The port is then sutured under the skin in area of the subclavian fossa. The port is accessed percutaneously using a noncoring needle that penetrates a silicone rubber septum at the top of the port. The port system is the mechanism with which fluids can pass into and out of the central venous system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the STD Med Primo Port, a totally-implantable vascular access device. The submission focuses on demonstrating substantial equivalence to a predicate device and meeting pre-determined acceptance criteria through bench testing.

Here's a breakdown of the requested information based on the provided text, with points that cannot be determined from the text explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance for each test. It states that "Performance data demonstrated that the STD Med Primo Port is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria." and that "The Primo Port meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness".

The categories of tests performed are listed under "Performance Testing":

Acceptance Criteria Category (Test Performed)	Reported Device Performance
Overall dimensions	Met pre-determined criteria
Septum durability	Met pre-determined criteria
Port leakage	Met pre-determined criteria
Fluid dynamics clearance	Met pre-determined criteria
Catheter-to-port connection	Met pre-determined criteria
Flow rate	Met pre-determined criteria
Obturation	Met pre-determined criteria
Priming volume	Met pre-determined criteria
Needle insertion & retention forces	Met pre-determined criteria
Stem strength	Met pre-determined criteria

Note: The actual quantitative criteria and specific numerical results are not detailed in the provided text, only that the device "met pre-determined acceptance criteria."

2. Sample Size used for the test set and the data provenance

Sample Size: Not specified in the document. The text only refers to "bench tests performed."
Data Provenance: Not applicable, as this was laboratory bench testing, not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was a physical device test, not a subjective assessment requiring expert ground truth in the way medical image analysis or clinical diagnosis would. The "ground truth" for these tests would be objective measurements against predefined engineering specifications.

4. Adjudication method for the test set

Not applicable. As this involves objective physical testing, there would be no subjective adjudication in the typical sense. Measurements would be taken, and they either pass or fail the pre-defined criteria.

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

No. This study is for a physical medical device (implantable port), not an AI/software device involving human readers or interpretation.

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

No. This is for a physical medical device, not an algorithm.

7. The type of ground truth used

Ground truth: Objective engineering specifications and performance standards established for device function (e.g., specific dimensions, leakage rates, force thresholds, flow rates). These "bench tests performed in accordance with FDA's October 1990 Guidance on 510(k) Submission for Implanted Infusion Ports" would have predefined metrics for passing.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI algorithm, so there is no "training set."

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

Not applicable. There is no training set for this type of device submission.

Summary

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2070411
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Section 5 - 510(k) Summary

AUG 1 0 2007

General Information

Owner's Name:Address:	STD Med., Inc.75 Mill StreetStoughton, Massachusetts 02072
Telephone Number:	(781)828-4400
Fax Number:	(781)344-5895
Contact Person:	Mark Orphanos
Subject Device Name:	STD Med Primo Port
Trade Name:	Primo Port
Common/Usual Name:	Titanium Subcutaneous Port & Catheter
Classification Name:	LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular InfusionPort and Catheter, Class II
Predicate Device Name:	BardPort® Implanted Port
Trade Name:	Titanium Port, Titanium Low-Profile Port
Common/Usual Name:	Titanium Subcutaneous Port & Catheter
Classification Name:	LJT - Port & Catheter, Implanted, Subcutaneous, Intravascular21 CFR 880.5965 - Subcutaneous, Implanted, Intravascular InfusionPort and Catheter, Class II
Premarket Notification:	K050310, concurrence date - April 18, 2005

Device Description

Intended Use

The STD Med Primo Port is a totally-implantable vascular access device designed to provide long term, repeated access to the vascular system.

Performance Testing

Performance data demonstrated that the STD Med Primo Port is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria. The risks associated with use of the new device were found acceptable when evaluated by FMEA.

Bench tests performed in accordance with FDA's October 1990 Guidance on 510(k) Submission for Implanted Infusion Ports included assessments of overall dimensions, septum durability, port leakage, fluid dynamics clearance, catheter-to-port connection, flow rate, obturation, priming volume, needle insertion & retention forces and stem strength.

No biocompatibility testing was conducted, all materials used in the manufacture of the Primo Port device have been previously cleared for similar devices.

Conclusion

The Primo Port meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the Primo Port is substantially equivalent to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2007

STD Med., Incorporated C/O Pamela Papineau, RAC President Delphi Medical Device Consulting, Incorporated 5 Whitcomb Avenue Ayer, Massachusetts 01432

Re: K070911

Trade/Device Name: STD Med Primo Port Regulation Number: 21 CFR 880.5965 Regulation Name: Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: July 20, 2007 Received: July 23, 2007

Dear Ms. Papineau:

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. Papineau

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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Section 4 - Indications for Use Statement

510(k) Number (if known):
K070911

Device Name: STD Med Primo Port

Indications for Use:

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-the -Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Charles Brown for ADW
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K020911

Regulation Number and Section

§ 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.