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

Device Description

Sterling Medivations Inc.'s ("SMI") Simplicity™ Simplex P Infusion Set is designed to provide a nicans to infuse or inject medication subcutaneously when attached to the MiniMed Paradigni infusion pump or syringe.

The Simplicity Simplex P Infusion Set is designed for use by people with diabetes to provide a means to infuse or inject medication subcutaneously when attached to the MiniMcd Paradigm influsion purpor syringe. It is inserted into the subcutaneous tissue of a patient and the Simplicity YP concector is stached to the medication reservoir. This is substantially equivalent to the predicate device and it has the same intendcd use.

The device cousists of four main parts: (1) an infusion catheter made from PTFE, (2) an infusion lub that provides the patient the capability of disconnecting the comnecting tube from the infusion catheren (3) a connecting tube and (4) a Simplicity YP connector consisting of a needle hub and reused causes. (1) a and reservoir connector.

The Simplicity Simplex P Infusion Set is an infusion administration set, connecting to the Paradig m reservoir by means of a Simplicity YP connector consisting of a needle but and reuseble purpose and rescrvoir connector and subcutancously in the patient through an indwelling catheter made of Polytetrafluorthylene (PTFE). The Stcrling Medivations Simplicity Simplex P Infusion Set may je used with any paradigm infusion device that delivers continuous or internattent flow. The connecting tubing is made from a polyethylene tube.

The 25 gauge-indwelling catheter is introduced into the subcutancous tissue by a removable 27-gauge insertion necdle formed from a lumen made of AISI 304 stainless stecl. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector ne-dle mates with the indwelling catheter forming a seal that permits the infusion of medication without leakage. The connector needle is made from AISI 304 stainless stcel and it is connected to the connecting tubing with a connector housing. The connector tubing proximal end is attached to a Simplicity YP connector consisting of a needle bub and reusable pump adapter and reservoir connection to a MiniMed Paradign pump and reservoir. The connecting tube is solvent bonded to the connector housing and to the aecdle hub

AI/ML Overview

The provided text describes a 510(k) submission for the "Simplicity™ Simplex P Infusion Set." This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance data from a specific study with acceptance criteria and results in the way typically seen for novel or high-risk devices.

Therefore, many of the requested categories like sample size, ground truth, expert qualifications, and MRMC studies are not applicable to the information contained in this 510(k) summary. The "acceptance criteria" here refer to conformity with established standards for similar devices.

Here's an attempt to structure the available information according to your request, with significant portions marked as "Not Applicable" or "Not Specified" due to the nature of the document:

Acceptance Criteria and Study to Prove Device Meets Criteria

The Simplicity™ Simplex P Infusion Set achieved substantial equivalence to predicate devices by demonstrating conformity to various international and national standards governing intravascular administration sets, sterilization, materials, and packaging. The "acceptance criteria" are therefore defined by successful adherence to these standards.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Governing Standard)	Reported Device Performance
CDRH 21 C.F.R. Section 880.5440 Intravascular administration set	Device meets the catheter requirements of this regulation.
ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements)	Device meets the catheter requirements of this standard.
ISO 10555 Sterile, single use intravascular catheters (Part 5: Peripheral Catheters)	Device meets the catheter requirements of this standard.
ISO 11135:1994 Medical devices -- Validation and routine control of ethylene oxide sterilization	Device manufacturing and sterilization processes adhere to this standard.
ISO 11138:1994 Sterilization of health care products -- Biological indicators -- Part 2: Ethylene oxide	Biological indicators for sterilization conform to this standard.
ISO 9626: 1991 Stainless Steel needle tubing for the manufacture of medical devices	Materials used for needle tubing conform to this standard.
ISO 11607: 1997 Packaging for terminally sterilized medical devices	Packaging for the device conforms to this standard.
ISO 8535: 1991 Sterile single use syringes, with or without needle, for insulin	Not explicitly stated how this applies to the infusion set, but listed.
ISO 10993: 1991 Bearing of the Limulus Amebocyte Lysate (LAL) Test as an end product	LAL test for endotoxin validation conforms for product release.
ODE Blue Book Memorandum #K90-1	Design process adheres to this guidance.
ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing	Biological evaluation of materials and device conforms to this standard.
Manufacturer's Quality System Requirements (e.g., QSR, ISO 9001)	Design process adheres to and comes under MANUFACTURERS. (Reference to QC guidance and ISO 9001)

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

Sample Size for Test Set: Not specified. The document indicates adherence to standards, which implies testing was conducted, but the specific number of units tested is not detailed in this summary.
Data Provenance: Not specified, but generally refers to internal company testing and validation processes in adherence to the listed standards.

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

Not applicable. The "ground truth" for this type of submission is conformity to established engineering and medical device standards. There is no mention of external experts or clinical judgement for performance evaluation in this summary.

4. Adjudication method for the test set

Not applicable. This is not a clinical study requiring adjudication of expert opinions.

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 assistive tool.

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

The "ground truth" implicitly used is conformity to established engineering and biocompatibility standards (e.g., ISO for sterility, materials, and intravascular catheters; CDRH regulations). This is demonstrated through various tests and validations that verify the device's physical, chemical, and biological properties meet the requirements of these standards.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model.

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

Not applicable. This is a medical device, not a machine learning model.

Summary

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MAY 0 3 2002

K021216

Sterling Medivations, Inc. 66 Neptune Drive Groton, CT 06340 650-814-4083(voice) 770-242-3178(fax)

510(k) SUMMAKY

Date Submitted: April 16, 2001

Submitter:	Sterling Medivations, Inc. 66 Neptune Drive, Groton, CT 06340Company Phone 650-814-4083, Company Fax 770-242-3178
Contact:	Jocl Douglas, Chief Technology OfficerSterling Medivations, Inc.Applicant Phone 650-814-4083Applicant Fax 770-242-3178
Trade Name of Device:	Simplicity™ Simplex P Infusion Set for use withthe MiniMed Paradigm infusion pumps.
Common Name of Device:	Intravascular administration set.
Classification Name:	Percutaneous intravascular catheter.
Predicate Device	Sterling Medivations, Sterling Medivations

Sterling Medivations Sterling Medivations Simplicity Simplex Soft Infusion Set, FDA 510 (k) K 020629 and Sterling Medivations Simplicity Soft YP Infusion Set K01187.

Description of the New Device: Sterling Medivations Inc.'s ("SMI") Simplicity™ Simplex P Infusion Set is designed to provide a nicans to infuse or inject medication subcutaneously when attached to the MiniMed Paradigni infusion pump or syringe.

Sterling Mcdivations, Inc. Simplicity Simplex P Infusion Set 510(k) Summary l'age 1 of 2

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connector.

Intended Use of the New Device: The intended use of the Simplicity Simplicx P Infusion Set is to provide a means to infose or inject medication subcutaneously when attached to the Minibed Paradigm infinion pump or syringc. The Simplicity Simplex Infision Set is substantially equivalent to the Sterling pulling of Syring. "The Bimplex Set K011187 and Simplicity Simplex Soft Infusion Set, ITTA S10 (k) K 020629.

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

The Simplicity Simplex P Infusion Set proposed for conmercial distributor in similar in all signification The onlinessy Business I Thereon Simplicity Soft YP Infusion Set K011187 and Simplicity Simplex Soft Infusion Set, FDA 510 (k) K 020629.

The matcrials and manufacturing processes are substantially equivalcnt, the labeling is substantially equivalent and it has the same intended use as the Sterling Medivations Simplicity Simplicity Simplex P Infusion.

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

The new device proximal end is a Simplicity YP connector consisting of needle hub and reusable 1. pump adapter and reservoir connector used to attach to a MiniMed Paradigm infusion pu mps and pullip adapter and reservour comments asserts the Sterling Medivations Simpling Simpling Simples of YP Infusion Set K011187 and the Device otherwise similar to the Simplicity Simplicity Simplex Soft . Infusion Set, FDA 510 (k) K 020629.
Performance Data Supporting Substantial Equivalence: To prove substantial equivalence both I Criol mance bata Bappor this Decessions Medivations Simplicity Simplex Infusion Sct FDA 5 . 0(x) K010373 meet 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 Stcrile, single use intravascular catheters (Part 5: Peripheral Catheters). .
ISO 11135:1994 Medical devices -- Validation and routine control of cthylenc oxide sterilization .
100 11133.1794 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. 9
ISO 11607: 1997 Packaging for terminally sterilized medical devices. .
ISO 8535: 1991 Sterile single use syringes, with or without needle, for insulin. .
100 0355. 1991 bearing of the Limulus Amebocyte Lysate (LAL) Test as an end product . PDA Onlines on validation of the Enemeral 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 adhcred to is the Center for Devices and Radiological Health. DESC(GN And the ucsign process bances to is and Comes CTURERS. This Guid: acc CONTROL GOLDANCE FOR MEDICAL DE . CONTRO 9001. This is substantially equivalent to the predicate device.

Signed,

Joel S. Douglas Chicf Technology Officer

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

MAY 0 3 2002

Re: K021216

Trade/Device Name: Simplicity Simplex P Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 16, 2002 Received: April 17, 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 vour 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. Joel Douglas

You must comply with all the Act's requirements, including, but not limited to: registration r ou indst comply with art 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), lacelity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality is a 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 110(k) premarket notification. The FDA finding of substantial equivalence of your device to 910(t) promaried nowledge 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 If you desire specific ad 1100 for in vitro diagnostic devices), please contact the and additionally 21 CF (301) 594-4618. Additionally, for questions on the promotion and Office of Confightance wee, 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 the Act may be obtained from the Brumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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K02/2/6

510(k) Number (if known):

Device Name: Simplicity Simplex P Infusion Set

Indications For Use:

(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)

Over-The-Counter Use

(Optional Format 1-2-96)

Patrice Accente

action Control, ﺔ ﺍﻟﻤ

Page 7 of 98

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.