KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501

K032827 · Tyco Healthcare · KSR · Dec 8, 2003 · Hematology

Device Facts

• Record ID: K032827
• Device Name: KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
• Applicant: Tyco Healthcare
• Product Code: KSR · Hematology
• Decision Date: Dec 8, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.9100
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The device is used for umbilical cord blood sampling and transfer. The device is intended for single use only.

Device Story

Kendall LifeTrace Umbilical Blood Collection Kit is a cup-shaped device divided into two halves. Top half collects umbilical cord blood and features a lid. Bottom half contains an Angel Wing transfer device with an attached needle assembly. Device facilitates transfer of collected blood from top chamber to a blood collection tube. Used in clinical settings for umbilical cord blood sampling. Benefits include simplified collection and transfer process for healthcare providers.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (in-vitro/in-vivo reactivity, pyrogenicity, hemolysis) and functional testing (liquid holding capacity, seal integrity, needle valve puncture durability, and aspiration capability). All tests met acceptance criteria.

Technological Characteristics

Polymer-based cup-shaped device; includes rubber valve, transfer set, and evacuated EDTA/no-additive blood collection tubes. Sterilization via irradiation. Complies with ISO 10993 for biological evaluation.

Indications for Use

Indicated for umbilical cord blood sampling and transfer. Single use only.

Regulatory Classification

Identification

An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.

Predicate Devices

• DeRoyal Surgical, Umbilicup (K02753)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K032827

B. Analyte:
N/A

C. Type of Test:
Kendall LIFETRACE Umbilical Blood Collection Kit

D. Applicant:
Tyco Healthcare

E. Proprietary and Established Names:
Kendall LIFETRACE Umbilical Blood Collection Kit

F. Regulatory Information:
1. Regulation section:
21 CFR 864.9100 Empty container for the collection and processing of blood and blood components
2. Classification:
Class II
3. Product Code:
KSR
4. Panel:
Hematology, 81

G. Intended Use:
1. Indication(s) for use:
The device is used for umbilical cord blood sampling and transfer. The device is intended for single use only.
2. Special condition for use statement(s):
N/A
3. Special instrument Requirements:
N/A

H. Device Description:
The Kendall LifeTrace Umbilical Blood Collection Device consists of a cup shaped body, divided in half. The top half is used to collect umbilical cord blood for analysis and has a lid. The bottom half contains an Angel Wing Transfer device that is used to

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puncture the rubber stoppers of vacuum tubes. The device is used to facilitate the transfer of the collected blood from the top chamber to the tube.

I. Substantial Equivalence Information:
1. Predicate device name(s): DeRoyal Surgical Umbilicup
2. Predicate K number(s): K020753
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The device is intended for single use only. The device is used for cord blood sampling and transfer | Same |
| Materials | Polymer based | Same |
| Device Description | Cup shaped device to contain blood | Same |
| | Contains a rubber valve over the blood collection needle | Same |
| | Contains cap for upper chamber | Same |
| | Contains sterile evacuated EDTA and no-additive blood collection tubes | Same |
| Differences | | |
| Item | Device | Predicate |
| Sterilization method | Irradiation | Ethylene oxide |

J. Standard/Guidance Document Referenced (if applicable): ISO 10993 for Biological Evaluation of Medical Devices Part-1
K. Test Principle: N/A
L. Performance Characteristics (if/when applicable):
1. Analytical performance:

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a. Precision/Reproducibility:
N/A

b. Linearity/assay reportable range:
N/A

c. Traceability (controls, calibrators, or method):
N/A

d. Detection limit:
N/A

e. Analytical specificity:
N/A

f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a and b are not applicable):
Biocompatibility Testing (Pass/Fail)
1. Biological Reactivity test, In-Vitro (Pass)
2. Limulus Amebocyte Lysate Procedure for Pyrogen Testing (Pass)
3. Biological Reactivity Test, In-Vivo (Pass)
4. Hemolysis Test (Pass)

Functional Testing
1. UBC device liquid holding capacity. (acceptance criteria met)
2. Integrity of the seal between the cap and funnel. (acceptance criteria met)
3. Integrity of the seal between the transfer set and the funnel. (acceptance criteria met)
4. Integrity of the seal between the rubber valve on the needle and the transfer set. (acceptance criteria met)
5. Integrity of the rubber valve after being punctured 8 times by a blood collection tube. (acceptance criteria met)
6. Ability to aspirate liquid into the evacuated blood collection tube while the cap is attached. (acceptance criteria met)

4. Clinical cut-off:
N/A

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5. Expected values/Reference range: N/A

**M. Conclusion:**
The Kendall LifeTrace Umbilical Blood Collection Kit has been shown to be substantially equivalent to the DeRoyal Surgical Umbilicup.