SIMPLICITY SOFT QD SILVER INFUSION SET by STERLING MEDIVATIONS, INC.

The intended use is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.

Device Description

Sterling Medivations, Inc.'s ("SMI") Simplicity ™ Soft QD Silver Infusion Set is designed for use by people with diabetes to provide a means to infuse insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.

The device consists of four main parts: (1) an infusion catheter made from FEP, (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 reservoir connector.

The Simplicity Soft QD Silver Infusion administration set, is designed for use by people with diabetes to provide a means to infuse insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow and inserted in the subcutaneous tissue of a patient. The Sterling Medivations Simplicity Soft QD Silver Infusion Set may be used with any infusion device that delivers continuous or intermittent flow.

The administration set attaches to the reservoir/syringe by means of a threaded reservoir connector, and subcutaneously in the patient through an indwelling catheter made of Fluorinated Ethylene Propylene (FEP). The connecting tubing is made from a polyethylene tube.

The 25 gauge-indwelling catheter is introduced into the subcutaneous tissue by a removable 27 gauge insertion needle made of AISI 304 stainless steel. The insertion needle is removed and a connector needle is attached to the indwelling catheter. This connector needle pierces a septum formits the infusion of medication without leakage. The connector needle is connecting tubing and a connector housing. The connector tubing proximal end is attached to a female Luer connector for attachment to the medicine reservoir. The connecting tube is solvent bonded to the connector housing and to the Luer connector. The quick disconnect allows the patient to temporally disconnect the pump reservoir from the indwelling catheter to better facilitate bathing and reservoir changes.

AI/ML Overview

The provided text describes a 510(k) summary for the "Simplicity™ Soft QD Silver Infusion Set." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with acceptance criteria and device performance metrics in the way a clinical trial report would.

Therefore, much of the requested information (like specific acceptance criteria based on performance, sample sizes for test sets, expert involvement, MRMC study details, training set information, or ground truth establishment for performance data) is not present in the provided document. The document primarily focuses on demonstrating that the new device meets established regulatory standards and has similar technological features and intended use as the predicate device.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Met by Simplicity™ Soft QD Silver Infusion Set)	Reported Device Performance (as stated in the document)
Compliance with CDRH 21 C.F.R. section 880.54400 Intravascular administration set	Implicitly met by design and testing against ISO standards. The text states: "To provide substantial equivalence the Simplicity Soft QD Silver Infusion Set meets the catheter requirements of: CDRH 21 C.F.R. section 880.54400 Intravascular administration set"
Compliance with ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements)	Implicitly met by design and testing against ISO standards. The text states it "meets the catheter requirements of" this standard.
Compliance with ISO 10555 Sterile, single use intravascular catheters (Part 5: peripheral catheters)	Implicitly met by design and testing against ISO standards. The text states it "meets the catheter requirements of" this standard.
Compliance with ISO 9626 Stainless steel needle tubing for the manufacture of medical devices	Implicitly met by design and testing against ISO standards. The text states it "meets the catheter requirements of" this standard.
Compliance with ISO 11135: 1994 Medical devices - Validation and routine control of ethylene oxide sterilization	Implicitly met by design and testing against ISO standards. The text lists this as a standard the device "meets."
Compliance with ISO 11138-2:1994 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization	Implicitly met by design and testing against ISO standards. The text lists this as a standard the device "meets."
Compliance with ISO 11607: 1997 Packaging for terminally sterilized medical devices	Implicitly met by design and testing against ISO standards. The text lists this as a standard the device "meets."
Compliance with ISO 8537: 1991 Sterile single use syringes, with or without needle for insulin	Implicitly met by design and testing against ISO standards. The text lists this as a standard the device "meets."
Compliance with FDA Guidelines on validation of the Limulus Amebocyte Lysate (LAL) Test as an end-product endotoxin test	Implicitly met by following FDA guidelines. The text lists this as a guideline the device "meets."
Adherence to Design Control Guidance for Medical Device Manufacturers (FDA 21 CFR 820.30 and ISO 9001 Sub-clause 4.4)	The design process "adhered to" this guidance.
Substantial Equivalence to Predicate Device (Sterling Simplicity™ Soft QD Easy Infusion set, K 010788)	"The Simplicity Soft™ QD Silver Infusion Set proposed for commercial distribution is similar in all significant respects to the existing the Simplicity Soft QD Easy Infusion Set, K010788 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 Soft QD Easy Infusion Set FDA 510(k) K010788."

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

The document does not provide specific sample sizes for performance testing in a clinical or user study context. The "tests" mentioned are compliance with standards and guidelines for manufacturing, sterilization, and catheter properties.
Data provenance is not specified beyond indicating compliance with international and US standards. There's no mention of country of origin for specific test data, nor is it described as retrospective or prospective clinical data. This is typical for a 510(k) where "substantial equivalence" is demonstrated through adherence to recognized manufacturing and materials standards, rather than new clinical efficacy studies.

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

This information is not provided. The document focuses on meeting established technical specifications and standards, which are typically defined by expert committees (e.g., ISO, FDA), but not in the context of individual experts establishing a "ground truth" for a specific test set for this device's performance.

4. Adjudication method for the test set

This information is not provided. As explained above, the "test set" here refers to compliance with standards, not a specific clinical performance study requiring adjudication.

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

This question is not applicable to the device described. The "Simplicity™ Soft QD Silver Infusion Set" is an insulin infusion set, a medical device for drug delivery, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance.

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

This question is not applicable. The device is an insulin infusion set, not an algorithm.

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

For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the established regulatory standards and guidelines (CDRH regulations, ISO standards for catheters, sterilization, packaging, LAL test guidelines, and design control guidance). The device's compliance with these pre-defined metrics serves as the "ground truth" for its safety and effectiveness relative to the predicate.

8. The sample size for the training set

This information is not provided and is not relevant for this type of device and submission. "Training sets" are typically associated with machine learning or AI algorithm development, which is not applicable here.

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

This information is not provided and is not relevant for this type of device and submission.

Summary

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Sterling Medivations, Inc. 180 Ferndale Road South Wayzata, Minnesota 55391 952-473-7971 (voice) 952473-4758 (fax)

510(k) SUMMARY
Date Submitted:	May 21, 2001
Submitter:	Sterling Medivations, Inc. 180 Ferndale Road South, Wayzata, MN 55391 Company Phone952-473-7971, Company fax 952-473-4758
Contact:	Joel Douglas, Chief Technology OfficerSterling Medivations, Inc.Applicant Phone 650-949-0470 or 650-814-4083, Applicant Fax 650-949-0342
Trade Name of Device:	Simplicity™ Soft QD Silver Infusion Set intended use is to provide a means to infuse orinject insulin subcutaneously when used with any infusion device that deliverscontinuous or intermittent flow.
Common Name of Device:	Intravascular administration set.
Classification Name:	Percutaneous intravascular catheter.
Predicate Device:	The predicate device for Sterling's Simplicity™ Soft QD Silver Infusion set is theSterling Simplicity™ Soft QD Easy Infusion set FDA 510(k) K 010788

Description of the New Device: Sterling Medivations, Inc.'s ("SMI") Simplicity ™ Soft QD Silver Infusion Set is designed for use by people with diabetes to provide a means to infuse insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.

The Simplicity ™ Soft QD Silver Infusion Set proposed for commercial distribution is similar in all significant respects to the existing the Simplicity Soft QD Easy Infusion Set, K010788 and it has the same intended use.

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Intended Use of the New Device: The intended use of the Simplicity Soft QD Silver Infusion Set is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.

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

The Simplicity Soft QD Silver Infusion Set proposed for commercial distribution is similar in all significant respects to the existing Simplicity Soft OD Easy Infusion Set 510(k) K010788.

The materials and manufacturing processes are substantially equivalent, the labeling is substantially equivalent and it has the same intended use as the Simplicity Soft QD Easy Infusion Set FDA 510(k) K010788.

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

The Simplicity Soft QD Silver Infusion Set has a threaded reservoir connector and the predicate device has a luer connector. The threaded reservoir connector is identical to the connector used on the Sterling Medivations Simplicity Silver Soft Infusion Set FDA K 010846.

Performance Data Supporting Substantial Equivalence: To provide substantial equivalence the Simplicity Soft QD Silver Infusion Set meets the catheter requirements of:

CDRH 21 C.F.R. section 880.54400 Intravascular administration set,

ISO 10555 Sterile, single use intravascular catheters (Part 1: General Requirements), and

ISO 10555 Sterile, single use intravascular catheters (Part 5: peripheral catheters).,

ISO 9626 Stainless steel needle tubing for the manufacture of medical devices,

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 11607: 1997 Packaging for terminally sterilized medical devices,

ISO 8537: 1991 Sterile single use syringes, with or without needle for insulin,

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.

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.

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

Signed
KLO

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 consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2001

Mr. Joel S. Douglas Chief Technology Officer Sterling Medivations, Incorporated 180 Ferndale Road South 22391 Wayzata, Minnesota

K011580 Re : Simplicity Soft QD Silver Trade/Device Name: Infusion Set 880.5440 Requlation Number: Requlatory Class: II Product Code: FPA Dated: May 21, 2001 May 22, 2001 Received:

Dear Mr. Douglas:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2 - Mr. Douglas

concerning your device in the Federal Register. Please note: this response to your premarket notification submission does chis responde co four might have under sections 531 through 542 of the Act for devices under the Electronic chrough 542 or cho notrol provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA debtribud in your alence of your device to a legally rinding of babboan device results in a classification for your marketed predicator mits 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 809.10 for in regulacion ostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on comprrance at (30) 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obcarned from chonomis (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

L.A. Alatrist

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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510(k) Number (if known):

Device Name: Simplicity Soft QD Silver Infusion Set

Indications For Use:

The intended use is to provide a means to infuse or inject insulin subcutaneously when used with any infusion device that delivers continuous or intermittent flow.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR (PER 21 CFR 801.109)

(Division Sign-Off) (Division of Dental, Infection Control and General Hospital Device 510(k) Number -

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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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.