(21 days)
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.
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).
The provided text is a 510(k) summary for a medical device (LifeShield® Latex-Free Primary IV Pump Set), focusing on its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics, sample sizes, expert involvement, or comparative effectiveness studies for AI/algorithm-based devices).
The document is a regulatory submission for a physical medical device, not a software or AI-driven device. Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance" or "standalone (i.e. algorithm only) performance," are not applicable to this type of submission.
The "study" referenced in this type of submission is typically a comparison of the new device to a legally marketed predicate device to demonstrate substantial equivalence, rather than a clinical trial with acceptance criteria for performance metrics as might be found for a novel AI diagnostic tool.
However, based on the information provided, here's an attempt to answer the relevant sections:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative manner with reported performance values for the new device against those criteria. Instead, it demonstrates substantial equivalence by comparing characteristics to a predicate device.
The closest equivalent to a performance claim and its fulfillment is regarding gravity flow protection:
| Acceptance Criteria (Implied from Predicate Comparison) | Reported Device Performance (Subject Device) |
|---|---|
| Provide gravity flow (free flow) protection at full vertical extension of the set (72 inches) limiting gravity flow to 1ml per hour (stated in description) | Limits 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). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) for a physical IV administration set, not a data-driven device that would involve a test set of data. The submission relies on comparative analysis of specifications and design to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no mention of experts or ground truth establishment for a test set in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described.
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
Not applicable. This is not an AI or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. There is no concept of "ground truth" as relevant to data-driven performance in this submission. The "truth" is established through engineering specifications, material compatibility, and demonstrated functional equivalence to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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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)
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- 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.
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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:
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- Both are used for intravenous infusion. with the Omni-Flow® Medication Management System™
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- 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.
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- 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®.
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- 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.
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- Both sets are not intended for use as a gravity set.
Differences:
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- The modified set contains two PAV"s located distal to the cassette. The current set has only (1) PAV located distal to the cassette.
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- The modified set has a total tubing length of 72 inches (nominal). The current set has a total tubing length of 110 inches (nominal).
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- 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 | DateSubmitted | ClearanceDate |
|---|---|---|---|
| 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 offluids from a container to a patient'svascular system. | Same |
| Indications for Use | The device is used with the Omni-Flow® Medication ManagementSystem™ for intravenous infusionby or under the order of a licensedmedical practitioner. The devicecan be used to simultaneouslyinfuse up to foursolutions/medications from bothsyringes and IV fluid containers. | Same |
| Technology | ||
| ➤ Basic OperatingPrinciple | Adminstration/infusion ofintravenous medications to apatient's vascular system with theassistance of an infusion pump. | Same |
| ➤ Gravity FlowProtection | Provide gravity flow (free flow)protection at full vertical extensionof the set (72 inches). | Provide gravity flow (free flow)protection up to a 36 inch headheight. |
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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(LN 12566) | Predicate Device(s)(LN 12162) |
|---|---|---|
| Technology (continued) | ||
| ➤ IV Line Type | Primary Patient Line | Same |
| ➤ Infusion PumpCompatibility | Omni-Flow® MedicationManagement 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) CollectionBag Port, (4) Secondary Line Ports | Same |
| ➤ Roller Clamp | Yes | Same |
| ➤ OPTION-LOK® MaleAdapter | 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 andSterilization | ||
| 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:
- 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,
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- the same manufacturing and sterilization processes, and
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- 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
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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 (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
..
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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
SECTION 1 Page 12
§ 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.