LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE

K033576 · Abbott Laboratories · FPA · Dec 4, 2003 · General Hospital

Device Facts

• Record ID: K033576
• Device Name: LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE
• Applicant: Abbott Laboratories
• Product Code: FPA · General Hospital
• Decision Date: Dec 4, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® is a single use device for the delivery of fluids from a container to a patient's vascular system.

Device Story

Single-use IV administration set designed for use with Omni-Flow® Medication Management Systems™; delivers fluids from containers to patient vascular system. Features include distal microbore patient line, convertible piercing pin, inline cassette, collection bag, CLAVE® connectors, and OPTION-LOK® adapters. Device incorporates two pressure-activated anti-siphon valves (PAVs) to limit gravity flow (free flow) to 1ml/hr when primed and hung at full 72-inch extension. Operated by healthcare professionals in clinical settings; not intended for gravity-only use. Output is controlled infusion of medications/fluids. Benefits include enhanced free-flow protection compared to single-valve predecessors.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing focused on gravity flow (free flow) protection capabilities at full 72-inch extension.

Technological Characteristics

Primary IV administration set; materials include polycarbonate (PAV housing) and silicone (PAV disc). Features two pressure-activated anti-siphon valves, distal microbore tubing (72 inches), inline cassette, and CLAVE®/OPTION-LOK® connectors. Non-electronic, mechanical flow control. Sterilized via standard manufacturing processes.

Indications for Use

Indicated for use with the Omni-Flow® Medication Management System™ for intravenous infusion by or under the order of a licensed medical practitioner. Used to simultaneously infuse up to four solutions/medications from syringes and IV fluid containers.

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

• LifeShield® Latex-Free Primary IV Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch, with CLAVE® and OPTION-LOK® (LN 12162)
• IV Administration Set with Backcheck Valve (K790062)
• OmniFlow Infusion Pump & IV Sets (K832755)
• OmniFlow Therapist Infusion System & IV Sets (K882594)
• Clave Connector (K915571)
• Abbott LTE Infusion Pump & IV Sets (K944125)
• Lifeshield Primary IV Set with Backcheck Valve (K971293)

Submission Summary (Full Text)

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K033576

LifeShicld® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, CLAVE® and OPTION-LOK®

DEC = 4 7003

# Special 510(K) Summary

1. Name of Submitter:

Abbott Laboratories Hospital Products Division 200 Abbott Park Road Abbott Park, Illinois 60064-6133

Establishment Registration # 1415939

#### 2. Manufacturer and Establishment Registration Number:

| Manufacturer | Sterilization Site |
|-------------------------------|----------------------------|
| Abbott Hospitals, Limited | Abbott Laboratories |
| Parque Industrial Itabo, S.A. | Hospital Products Division |
| Haina, San Cristobal | Hwy. 301 North |
| Dominican Republic | Rocky Mount, NC 27801 |

Establishment Registration # 9613251

Establishment Registration # 1021343

- 3. Proprietary or Trade Name: LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® (LN 12566)
- 4. Common Name: Set, Administration Intravascular
- 5. Device Classification, Pancode and ProCode: Class II, 80, FPA
- 6. Performance Standards: Performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Set, Administration Intravascular. Set Administration Intravascular can be found in 21 CFR 880.5440.

#### 7. Intended Use:

LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® is a single use device for the delivery of fluids from a container to a patient's vascular system.

The intended use and indications for use are the same as other commercially available IV administration sets designated for use with the Omni-Flow® Medication Management Systems™. This set is not intended for gravity use.

#### 8. Indications for Use:

The device is used with the Omni-Flow® Medication Management System™ for intravenous infusion by or under the order of a licensed medical practitioner. The device can be used to simultaneously infuse up to four solutions/medications from both syringes and IV fluid containers.

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LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, CLAVE® and OPTION-LOK®

### 9. Device Description:

The LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® is designed to be used exclusively with Omni-Flow® Medication Management Systems™. The set is equipped with two pressure-activated anti-siphon valves. The two valves limit gravity flow (free flow) to 1ml per hour when the set is primed and attached to a solution bag hanging vertically at full set extension (72 inches).

### 10. Statement of Substantial Equivalence:

The LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® is substantially equivalent to the LifeShield® Latex-Free Primary IV Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch, with CLAVE® and OPTION-LOK® (LN 12162).

The modified primary set (LN 12566) is substantially equivalent to currently marketed primary set (LN 12162 in that :

### Similarities:

- 1) Both are used for intravenous infusion. with the Omni-Flow® Medication Management System™
- 2) Both can be used with the Omni-Flow® Medication Management System™ for intravenous infusion by or under the order of a licensed medical practitioner. Both devices can be used to simultaneously infuse up to four solutions/medications from both syringes and IV fluid containers.
- 3) Both are latex-free primary sets consisting of a Distal Microborc Patient Line, Convertible Pin, Inline Cassette, Collection Bag, (1) Integral Y-High Clave at the distal end of the patient line, and OPTION-LOK®.
- 4) Both sets have at least (1) Pressure Activated Anti-Siphon Valve (PAV) to provide free flow protection under specific head height conditions.
- 5} Both sets have components made from the same or similar material.
- 6) Both sets are not intended for use as a gravity set.

## Differences:

- 1) The modified set contains two PAV"s located distal to the cassette. The current set has only (1) PAV located distal to the cassette.
- 2) The modified set has a total tubing length of 72 inches (nominal). The current set has a total tubing length of 110 inches (nominal).
- 3) The PAV's in the modified set contain a comparable silicone material cleared under K790062 (IV Administration Set with Backcheck), and are currently manufactured and sold by B. Braun Medical Inc. as a bulk /non-sterile item.

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## LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, CLAVE® and OPTION-LOK®

### 11. Predicate Device Information:

Information for IV Administration sets/set components previously cleared for commercial distribution and determined to be appropriate for use as predicates is provided below.

| 510(k) # | Product Name | Date<br>Submitted | Clearance<br>Date |
|----------|------------------------------------------------------------------|-------------------|-------------------|
| K790062 | IV Administration Set with Backcheck Valve<br>(B. Braun Medical) | 01/10/79 | 04/10/79 |
| K832755 | OmniFlow Infusion Pump & IV Sets | 08/09/83 | 11/03/83 |
| K882594 | OmniFlow Therapist Infusion System & IV Sets | 06/21/88 | 09/20/88 |
| K915571 | Clave Connector (ICU Medical) | 12/12/91 | 09/21/92 |
| K944125 | Abbott LTE Infusion Pump & IV Sets | 08/16/94 | 12/06/94 |
| K971293 | Lifeshield Primary IV Set with Backcheck Valve | 04/04/97 | 06/27/97 |

## 12. Comparison to Legally Marketed Device(s)

| Factors | Subject Device<br>(LN 12566) | Predicate Device(s)<br>(LN 12162) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Intended Use | Single use device for the delivery of<br>fluids from a container to a patient's<br>vascular system. | Same |
| Indications for Use | The device is used with the Omni-<br>Flow® Medication Management<br>System™ for intravenous infusion<br>by or under the order of a licensed<br>medical practitioner. The device<br>can be used to simultaneously<br>infuse up to four<br>solutions/medications from both<br>syringes and IV fluid containers. | Same |
| Technology | | |
| ➤ Basic Operating<br>Principle | Adminstration/infusion of<br>intravenous medications to a<br>patient's vascular system with the<br>assistance of an infusion pump. | Same |
| ➤ Gravity Flow<br>Protection | Provide gravity flow (free flow)<br>protection at full vertical extension<br>of the set (72 inches). | Provide gravity flow (free flow)<br>protection up to a 36 inch head<br>height. |

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# LifeShield® Latex-Frec Primary IV Pump Set Distal Microbore Patient Linc, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, CLAVE® and OPTION-LOK®

| Factors | Subject Device<br>(LN 12566) | Predicate Device(s)<br>(LN 12162) |
|--------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------|
| Technology (continued) | | |
| ➤ IV Line Type | Primary Patient Line | Same |
| ➤ Infusion Pump<br>Compatibility | Omni-Flow® Medication<br>Management Systems™ | Same |
| ➤ Infusion Fluid Types | General Hospital | Same |
| Design/Components | | |
| ➤ Pressure Activated Anti-<br>Siphon Valves (PAV) | (2) PAV's | (1) PAV |
| ➤ Semi-Rigid Adapters<br>(bonds PAV to set) | (4) Semi-Rigid Adapters | (1) Semi-Rigid Adapter |
| ➤ Access Sites | (1) Integral Y-High Clave (distal) | Same |
| ➤ Total Tubing Length | 72 inches (Nominal) | 110 inches (Nominal) |
| ➤ Tubing Type | Distal Microbore | Same |
| ➤ Convertible Piercing Pin | Yes | Same |
| ➤ CAIR Clamp | Yes | Same |
| ➤ Drip Chamber | Yes | Same |
| ➤ In-Line Integral Cassette | (1) Patient Line Port, (1) Collection<br>Bag Port, (4) Secondary Line Ports | Same |
| ➤ Roller Clamp | Yes | Same |
| ➤ OPTION-LOK® Male<br>Adapter | Yes | Same |
| ➤ Slide Clamp | Yes | Same |
| ➤ Collection Bag | Yes | Same |
| Materials | | |
| ➤ Pressure Activated Anti-<br>Siphon Valves (PAV)<br>Housing | Polycarbonate | Same |
| ➤ Pressure Activated Anti-<br>Siphon Valves (PAV),<br>Disc | Silicone | Same |
| ➤ All Other Components | Same | Same |
| Manufacturing Processes and<br>Sterilization | | |
| All Components | Same | Same |
| Packaging | | |
| ➤ Assembled Set | Paperboard Carton | Same |
| ➤ Shipping Container | Corrugated Fiberboard | Same |

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LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, CLAVE® and OPTION-LOK®

# 13. Summary of Safety and Effectiveness

The LifeShield® Latex-Free Primary IV Pump Set Distal Microborc Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, CLAVE® and OPTION-LOK® (I.N 12566) as described in this submission is substantially equivalent to the predicate Lifeshield Primary Set (LN 12162), in that both sets have:

1) the same intended use,

- 2) the same indication for use,
- 3) the same fundamental technology and operating principle,
- 4) the same or similar materials of construction for all components,
- 5) the same manufacturing and sterilization processes, and
- 6) the same packaging.

#### 14. Statement of Safety and Effectiveness

The LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch,with 2 Pressure-Activated Anti-Siphon Valves, CLAVE® and OPTION-LOK® (LN 12566) mects the functional claims and intended use as described in the product labeling, and is substantially equivalent to, and as safe and effective as, the LifeShield® Latex-Free Primary Pump Set with Distal Microbore Patient Line, Convertible Pin, 110 Inch, with Pressure-Activated Anti-Siphon Valve, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® (LN 12162).

Prepared and submitted November 12, 2003 by: (- 1 frea W sleech Patricia Melerski Manager Regulatory Affairs Device Registration Abbott Laboratories Hospital Products Division D389, J45-2N 200 Abbott Park Road, IL 60064-6133 Phone: [phone] Fax: [phone]

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 4 2003

Abbott laboratories Ms. Patricia Melerski Manager, Regulatory Affairs Device Registration Hospital Products Division D-389, Bldg. J45-2N 200 Abbott Park Road Abbott, Park, Illinois 60064-6133

Re: K033576

Trade/Device Name: LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION- LOK® (LN 12566) Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 12, 2003 Received: November 13, 2003

Dear. Ms. Melerski:

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.

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Page 2 - Ms. Melerski

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. or me ret or myly 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Susan Rumm

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

..

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LifeShicid® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, CLAVE® and OPTION-LOK®

# Indications for Use Statement 510(k) Number (if known) Device LifeShield® Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Name: Convertible Pin, 72 Inch, with 2 Pressure-Activated Anti-Siphon Valves, Inline Cassette, Collection Bag, CLAVE® and OPTION-LOK® (LN 12566) Indications LifeShield® Latex-Free Primary IV Pump Set (LN12566) has the following For Use: indications for use: The device is used with the Omni-Flow Medication Management System™ for intravenous infusion by or under the order of a licensed medical practitioner. The device can be used to simultaneously infuse up to four solutions/medications from both syringes and IV fluid containers. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The Counter Use (per 21 CFR 801.109) 17 (Division Sign-Off)

(Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: KD133576

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