EVANS SUB-Q, MODEL MC4206

K020530 · Evans Medical, Inc. · FPA · Apr 29, 2002 · General Hospital

Device Facts

• Record ID: K020530
• Device Name: EVANS SUB-Q, MODEL MC4206
• Applicant: Evans Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Apr 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Evans Sub-Q (Catalog # MC4206) Winged Subcutaneous Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe. (The device is supplied sterile, for single use only. It is a prescription device)

Device Story

Evans Sub-Q is a sterile, single-use winged subcutaneous tissue infusion set. Device components include a 90-degree needle mounted to a butterfly stabilizer, 42-inch medical-grade tubing, and a luer lock connector for attachment to an external infusion pump or syringe. An adhesive dressing is included to secure the device to the patient. The device facilitates the delivery of medication into subcutaneous tissue. It is intended for prescription use.

Clinical Evidence

Bench testing only. Performance testing confirmed the device satisfies design intent.

Technological Characteristics

Winged subcutaneous infusion set; 90-degree stainless steel needle; 42-inch medical-grade tubing; luer lock connector; adhesive dressing; sterile; single-use.

Indications for Use

Indicated for patients requiring subcutaneous infusion of medicine delivered via an external infusion pump or syringe.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Minimed MMT-106, MMT-107, MMT-133 (K961474)

Submission Summary (Full Text)

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Ko20530

APR 2 9 2002

### EXHIBIT 2

Evans Medical, Inc. 295 Old Limekiln Road Chalfont, PA 18914 Phone [phone] Fax [phone] Contact: Paul Lambert January 7, 2002

# 510(k) Summary of Safety and Effectiveness

- 1. Identification of the Device: Proprietary-Trade Name: "Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Tissue Infusion Set Classification Name: FPA Common/Usual Name: I.V. Administration Set
- 2. Equivalent legally marketed device: This device is similar in design and in function to the Minimed MMT-106. MMT-107, MMT-133, K961474.
- 3. Indications for Use (intended use): "Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe. (The device is supplied sterile, for single use only. It is a prescription device)
- 4. Description of the device: The device consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The infusion set has a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end, connected by 42" of 2mm medical grade tubing. The luer lock connects to the infusion pump device. The device is for single use.

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- 5. Safety and Effectiveness, comparison to predicate device:

| Comparison Areas | Minimed MMT-106. MMT-<br>107, MMT-133, K961474; | "Evans Sub-Q" (Catalog #<br>MC4206) Winged<br>Subcutaneous Tissue<br>Infusion Set |
|---------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Indications for use | Intended to provide<br>subcutaneous infusion of<br>medicine from an external<br>infusion pump | Intended to provide<br>subcutaneous infusion of<br>medicine from an external<br>Infusion pump or syringe |
| Materials | Medical grade plastics and<br>stainless steel needle | SAME |
| Packaging | Packed sterile for single<br>patient use | SAME |

- 6. Testing information and Conclusion
1 esting information and Coxectars Sub-Q'' (Catalog # MC4206) Winged In an material respons, are is substantially equivalent to several similar devices Subculancous Intusion between betting was performed according to internal company ancady on the OD mance. Testing many was actual device performance satisfies the design intent.

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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 lines forming its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 9 2002

Evans Medical, Incorporated C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K020530

Trade/Device Name: Evans SUB-Q ( Catalog MC4206) Winged Subcutaneous Tissue Infusion Set Regulation Number: 880.5440 Regulation Name: I.V. Adminstration Set Regulatory Class: II Product Code: FPA Dated: February 18, 2002 Received: February 19, 2002

#### Dear Mr. Kamm:

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

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#### Page 2 - Mr. Daniel Kamm

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal buts requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF R Part 007), as clima (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the qualify 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 310(K) promised notificate 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 II you desire specific act 100 for in vitro diagnostic devices), please contact the Office of Compliance at [phone] . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. ad vertibing or joint on 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 ret may be volumer at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy W. Klatowski

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

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K020530

### j) Indications for Use

510(k) Number K020530

510(k) Namber K02053 -Evalis Sub-Q (Catalog in IPO 1200) Nation of medicine from an external infusion pump or syringe. .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

OR

Over the Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Patrice Cucenile

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