The intended use of the Simplicity Easy Access P Infusion Set is to provide a means for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.

Device Description

Sterling Medivations Inc.'s ("SMI") Simplicity Easy Access P designed for use by people with diabetes for the infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe. It is inserted into thssue of a patient and the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Access Infusion Set, K014062 and Soft YP Infusion Set, FDA 510 (k) K011187.

The Simplicity Easy Access P Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Access Infusion Set, FDA 510 (k) K014062 and it has the same intended use.

The device consists of four main parts: (1) infusion catheters made from AISI 304 stainless steel, (2) an infusion hub that provides the patient the capability of disconnecting tube from the infusion catheter, (3) a connecting tube and (4) a threaded YP connector.

The Simplicity Easy Access P Infusion Set is an infusion administration set, connecting to a medicine reservoir or syringe that is placed in an external infusion device and inserted below the surface of the skin of a patient. The SMI Simplicity Easy Access Infusion Set may be used with any Paradigm infusion device that delivers continuous or intermittent flow.

The administration set attaches to the reservoir/syringe by means of a threaded YP connector, and under the surface of the skin in the patient through an indwelling needles formed from AISI 304 stainless steel. The connecting tubing is made from a polyethylene tube.

The indwelling needles formed from AISI 304 stainless steel are introduced below the surface of the skin. The connector needle is attached to the indwelling catheter. This seal on the connector needle mates with the indwelling catheter hub that forms a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless steel and it is connecting tubing. The connector tubing proximal end is attached to a threaded YP connector for attachment to the Paradigm medicine reservoir.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Simplicity™ Easy Access P Infusion Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a formal study with detailed acceptance criteria and performance data as might be found for a new and novel device.

Therefore, much of the requested information (acceptance criteria in terms of performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or not present in this type of regulatory document.

However, based on the information provided, here's what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly presented in the typical format of performance metrics and thresholds. Instead, the "acceptance criteria" are compliance with established medical device standards and the "reported device performance" is the demonstration that the device meets these standards, thus proving substantial equivalence.

Acceptance Criteria (Compliance with Standards/Regulations)	Reported Device Performance (Demonstrated Equivalence)
CDRH 21 C.F.R. Section 880.5440 (Intravascular administration set)	Device meets these requirements for an intravascular administration set.
ISO 10555 Part 1: General Requirements (Sterile, single use intravascular catheters)	Device meets these requirements for sterile, single-use catheters.
ISO 10555 Part 5: Peripheral Catheters (Sterile, single use intravascular catheters)	Device meets these requirements for peripheral catheters.
ISO 11135:1994 (Validation and routine control of ethylene oxide sterilization)	Device sterilization process validated according to this standard.
ISO 11138-2:1994 (Biological indicators for ethylene oxide sterilization)	Biological indicators for sterilization comply with this standard.
ISO 9626: 1991 (Stainless Steel needle tubing for medical devices)	Stainless steel needle tubing complies with this standard.
ISO 11607: 1997 (Packaging for terminally sterilized medical devices)	Device packaging complies with this standard.
ISO 8535: 1991 (Sterile single use syringes, with or without needle, for insulin)	Device is compatible with sterile single-use insulin syringes as per this standard.
FDA Guidelines on LAL Test validation	Endotoxin testing complies with FDA guidelines.
ODE Blue Book Memorandum #K90-1	Device testing followed guidelines from this memorandum.
ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and testing)	Device biocompatibility evaluated according to this standard.
Center for Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS (21 CFR 820.30 and ISO 9001 Sub-clause 4.4)	Device design process adhered to these guidance documents.
Substantial Equivalence to Predicate Device (Simplicity™ Easy Access Infusion Set, K014062)	Device is substantially equivalent in materials, manufacturing, labeling, and intended use.

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

Sample Size: Not specified. The document states that the device "meets the catheter requirements of" various ISO standards and FDA guidelines, implying that relevant tests were conducted. However, the specific sample sizes for these tests are not provided in this summary.
Data Provenance: Not specified, but implied to be from internal testing conducted by Sterling Medivations, Inc. to ensure compliance with the listed standards. This would be prospective testing for regulatory submission.

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

This type of information is not relevant for a 510(k) submission concerning an infusion set. Ground truth, in the context of diagnostic or AI devices, refers to a definitive correct answer for a medical condition. For an infusion set, compliance is demonstrated through engineering and biocompatibility testing against established standards, not expert clinical assessment of "ground truth."

4. Adjudication method for the test set

Not applicable/not specified. Adjudication methods are typically employed in clinical trials or studies where there's subjectivity in outcome assessment, often involving multiple expert readers. This is not reported for the testing of an infusion set.

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

Not applicable. This device is an infusion set, not an AI-powered diagnostic or decision support tool. Therefore, MRMC studies and AI assistance metrics are irrelevant.

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

Not applicable. This device is an infusion set, not an algorithm.

7. The type of ground truth used

Not applicable in the conventional sense of clinical ground truth (e.g., pathology for a diagnosis). The "ground truth" for this device's performance is adherence to established engineering specifications, material standards (e.g., AISI 304 stainless steel), biocompatibility criteria (ISO 10993-1), sterility standards (ISO 11135), and regulatory requirements. The tests verify that the device physically functions and is manufactured safely according to these pre-defined standards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary

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Sterling Medivations, Inc. 66 Neptune Drive Groton, CT 06340 650-814-4083 (voice) 770-242-8639 (fax)

510(k) SUMMARY

Date Submitted: May 7, 2002

Submitter:	Sterling Medivations, Inc. 66 Neptune Drive, Groton, CT 94022Company Phone 650-814-4083, Company Fax 770-242-8639
Contact:	Joel Douglas, Chief Technology OfficerSterling Medivations, Inc.Applicant Phone 650-814-4083 or 770-242-8639

Trade Name of Device: Simplicity™ Easy Access P Infusion Set for infusion and/or injection of fluids into the body below the surface of the skin when attached to an external pump or syringe

Common Name of Device:	Intravascular administration set.
Classification Name:	Percutaneous intravascular catheter.

FDA/CORH/00MC
RECEIVE MAY 8 3 1802Simplicity Easy Access Infusion Set, FDA 510 (k) K014062. Predicate Device:

Description of the New Device: Sterling Medivations Inc.'s ("SMI") Simplicity Easy Access P designed for use by people with diabetes for the infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe. It is inserted into thssue of a patient and the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Access Infusion Set, K014062 and Soft YP Infusion Set, FDA 510 (k) K011187.

Intended Use of the New Device: The intended use of the Simplicity Easy Access P Infusion Set is to provide a means to for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.

SK시

Sterling Medivations, Inc. Simplicity Easy Access P Infusion Set 510(k) Summary

Page 1 of 2

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Comparison of the Technological Features of the New Device and Predicate Device:

The Simplicity Easy Access Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Easy Access Infusion Set, FDA 510 (k) K014062 and it has the same intended use.

The materials and manufacturing processes are substantially equivalent, the labeling is substantially equivalent and it has the same intended use as the Simplicity Easy Access Infusion Set.

The differences that exist between the new and predicate device are as follows:

The Simplicity Easy Access P Infusion Set has a 360 degree rotating infusion hub attached to the connecting tube and the predicate device has a fixed infusion hub attached to the connecting tube. The 360 degree rotating hub and connector is equivalent to the hub and connector on the Sterling Medivations Soft QD II Infusion Set, K020990.
The Simplicity Easy Access P Infusion Set has is sold in two package configurations a complete 10 pack and a 5/10 package consisting of 10 indwell housing hubs and 5 connecting tubes for patient that change their indwell housing hubs more frequently than every 72 hours. This is similar to the packaging provided by the Maersk Medical Contour™ Infusion Set, K991759 sold as the MiniMed Silhouette.
The Simplicity Easy Access P Infusion Set indwelling catheter connector is designed for use with the MiniMed Paradigm pump which is equivalent to the YP connector on the Sterling Medivations Simplicity Soft YP Infusion Set K011187.

Performance Data Supporting Substantial Equivalence: To prove substantial equivalence the Simplicity Easy Access Infusion Set meets the catheter requirements of:

CDRH 21 C.F.R. Section 880.5440 Intravascular administration set .
ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements) .
ISO 10555 Sterile, single use intravascular catheters (Part 5: Peripheral Catheters). .
ISO 11135:1994 Medical devices -- Validation and routine control of ethylene oxide sterilization ●
ISO 11138-2:1994 Sterilization of health care products -- Biological indicators -- Part 2: Biological indicators . for ethylene oxide sterilization.
. ISO 9626: 1991 Stainless Steel needle tubing for the manufacture of medical devices.
ISO 11607: 1997 Packaging for terminally sterilized medical devices. ●
ISO 8535: 1991 Sterile single use syringes, with or without needle, for insulin. .
FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end product endotoxin test . for human and animal parenteral drugs, biological products, and medical devices.
. ODE Blue Book Memorandum #K90-1.
ISO 10993-1. Biological evaluation of medical devices Part 1: Evaluation and testing. .

And the design process adhered to is the Center for Devices and Radiological Health. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS. This Guidance relates to FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001. This is substantially equivalent to the predicate device.

Signed,

J.E.E.Z

Joel S. Douglas Chief Technology Officer

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three horizontal lines above it, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2002

Mr. Joel Douglas Chief Technology Officer Sterling Medivations, Incorporated 66 Neptune Drive Groton, Connecticut 06340

Re: K021487

Trade/Device Name: Simplicity Easy Access P Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 7, 2002 Received: May 8, 2002

Dear Mr. Douglas:

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.

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.

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Page 2 - Mr. Douglas

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

for Susan Runner

Timothy A. Ulatowski Director Division of Dental. Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko21487

510(k) Number (if known):

Device Name: Simplicity Easy Access P Infusion Set

Indications For Use:

The intended use of the Simplicity Easy Access P Infusion Set is to provide a means @ for infusion and/or injection of fluids into the body below the surface of the skin when attached to a MiniMed Paradigm pump or syringe.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (PER 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Patrucci Curente
(Division Sign-Off)

Division Of Dental, Infection Control, and General Hospital Hospital Device 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Page 7 of 88

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.