(21 days)
No
The 510(k) summary describes a standard IV administration set with mechanical components (valves) and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No No
The device is an IV administration set, used for delivering fluids to a patient's vascular system. It is a delivery mechanism, not a device that provides therapy itself.
No
The device is an IV pump set used for the delivery of fluids and medications to a patient's vascular system, which is a therapeutic function, not diagnostic.
No
The device description clearly outlines a physical IV pump set with various hardware components like valves, a cassette, a collection bag, and connectors, designed for fluid delivery. It is not described as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of fluids from a container to a patient's vascular system." This describes a device used for administering substances directly into the body, not for testing samples taken from the body.
- Device Description: The description focuses on the components and function of an IV administration set used with an infusion pump. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such analysis.
Therefore, the LifeShield® Latex-Free Primary IV Pump Set is a medical device used for fluid administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
FPA
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical practitioner / General Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K790062, K832755, K882594, K915571, K944125
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
- 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
-
- 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)
-
- Common Name: Set, Administration Intravascular
-
- Device Classification, Pancode and ProCode: Class II, 80, FPA
-
- 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.
1
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:
-
- Both are used for intravenous infusion. with the Omni-Flow® Medication Management System™
-
- 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.
-
- 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®.
-
- 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.
-
- Both sets are not intended for use as a gravity set.
Differences:
-
- The modified set contains two PAV"s located distal to the cassette. The current set has only (1) PAV located distal to the cassette.
-
- The modified set has a total tubing length of 72 inches (nominal). The current set has a total tubing length of 110 inches (nominal).
-
- 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.
2
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
Submitted | Clearance
Date |
|----------|------------------------------------------------------------------|-------------------|-------------------|
| K790062 | IV Administration Set with Backcheck Valve
(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
(LN 12566) | Predicate Device(s)
(LN 12162) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Intended Use | Single use device for the delivery of
fluids from a container to a patient's
vascular system. | Same |
| 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. | Same |
| Technology | | |
| ➤ Basic Operating
Principle | Adminstration/infusion of
intravenous medications to a
patient's vascular system with the
assistance of an infusion pump. | Same |
| ➤ Gravity Flow
Protection | Provide gravity flow (free flow)
protection at full vertical extension
of the set (72 inches). | Provide gravity flow (free flow)
protection up to a 36 inch head
height. |
3
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
(LN 12566) | Predicate Device(s)
(LN 12162) |
|--------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------|
| Technology (continued) | | |
| ➤ IV Line Type | Primary Patient Line | Same |
| ➤ Infusion Pump
Compatibility | Omni-Flow® Medication
Management Systems™ | Same |
| ➤ Infusion Fluid Types | General Hospital | Same |
| Design/Components | | |
| ➤ Pressure Activated Anti-
Siphon Valves (PAV) | (2) PAV's | (1) PAV |
| ➤ Semi-Rigid Adapters
(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
Bag Port, (4) Secondary Line Ports | Same |
| ➤ Roller Clamp | Yes | Same |
| ➤ OPTION-LOK® Male
Adapter | Yes | Same |
| ➤ Slide Clamp | Yes | Same |
| ➤ Collection Bag | Yes | Same |
| Materials | | |
| ➤ Pressure Activated Anti-
Siphon Valves (PAV)
Housing | Polycarbonate | Same |
| ➤ Pressure Activated Anti-
Siphon Valves (PAV),
Disc | Silicone | Same |
| ➤ All Other Components | Same | Same |
| Manufacturing Processes and
Sterilization | | |
| All Components | Same | Same |
| Packaging | | |
| ➤ Assembled Set | Paperboard Carton | Same |
| ➤ Shipping Container | Corrugated Fiberboard | Same |
4
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:
- the same intended use,
-
- the same indication for use,
-
- the same fundamental technology and operating principle,
-
- the same or similar materials of construction for all components,
-
- the same manufacturing and sterilization processes, and
-
- 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: 847/938-3718 Fax: 847/938-7867
5
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.
6
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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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
..
7
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
SECTION 1 Page 12