EZ REGULAR

K080303 · Meinntech Co., Ltd. · FPA · Aug 5, 2008 · General Hospital

Device Facts

• Record ID: K080303
• Device Name: EZ REGULAR
• Applicant: Meinntech Co., Ltd.
• Product Code: FPA · General Hospital
• Decision Date: Aug 5, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The EZ Regular set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. Prescription Use.

Device Story

EZ Regular is an intravascular administration set used to deliver fluids from a container to a patient's vascular system. Components include an air-vented bag spike, drip chamber (with or without filter), roller clamp, tubing, flow controller, Y-connector, needle-less Y-connector, luer lock end catheter, and manifold filter. The device is operated by healthcare professionals in clinical settings. It functions as a standard fluid delivery conduit; no electronic or software components are involved. The device facilitates fluid therapy, supporting patient hydration or medication administration.

Clinical Evidence

Bench testing only. Testing included biocompatibility, mechanical performance, and sterility (including EO residues). Results demonstrated the device is safe and performs equivalently to the predicate.

Technological Characteristics

Intravascular administration set consisting of PVC/plastic tubing, spike, drip chamber, roller clamp, flow controller, Y-connectors, and luer lock. EO sterilized. No electronic components, software, or energy source.

Indications for Use

Indicated for patients requiring intravenous or intra-arterial fluid administration via needle or catheter.

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

• Kipp Group Intravascular Administration Set (K991932)

Submission Summary (Full Text)

{0}------------------------------------------------

### 510(K) Summary

### K08030 3

AUG - 6 2008

### MEINNTECH CO., LTD. # 502, Pyeongchon IT B/D, 1113-1, Daran-dong, dongan-gu, Anyang-si, gyeonggi-do, Korea

Contact person: Contact : Ui-soo Kim, Overseas Sales Manager Korea Telephone : [phone] Fax [phone] E-mail: [e-mail] Date Prepared: February 1, 2008

- 1. Trade Name: EZ Regular Common Name: Intravascular administration set. Classification Name: Intravascular administration set. Product code FPA, Regulation: 880.5440 Class of device: Class II.
- 2. The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : Kipp Group Intravascular Administration Set (K991932)
- 3. Description of device: The EZ Regular consists of components commonly found on intravascular administration sets and extension sets.

EZ Regular set consists of various components such as:

- air vented bag spike. .
- drip chamber with filter or without filter, .
- roller clamp, tubing. .
- flow controller. .
- Y-connector, .
- needle-less Y-connector, .
- luer lock end catheter, .
- manifold filter. .
- 4. Intended use: The EZ Regular set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. Prescription Use.
- 5. The EZ Regular Administration Sets and the predicate Technological characteristics: devices have identical technological characteristics and perform the same way as common intravascular administration sets. They are EO sterilized.
- 6. Performance: Bench tests were performed. Bench testing included biocompatibility. mechanical testing, sterility testing including EO residues. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.

{1}------------------------------------------------

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The text is written in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG - 6 2008

Meinntech Company, Limited C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K080303

Trade/Device Name: EZ Regular Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 29, 2008 Received: August 1, 2008

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.

{2}------------------------------------------------

### Page 2 - Mr. Kamm

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

MKormels-Verdi-forll

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

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known):_K08 ○ 30 3

Device Name: _ EZ Regular

Indications For Use:

The EZ Regular set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jot All der Daomin

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: _______________________________________________________________________________________________________________________________________________________________