(89 days)
The device is used for umbilical cord blood sampling and transfer. The device is intended for single use only.
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 facilitate the transfer of the collected blood from the top chamber to the tube.
This 510(k) summary (K032827) for the Kendall LifeTrace Umbilical Blood Collection Kit primarily focuses on establishing substantial equivalence to a predicate device based on shared intended use and technological characteristics, rather than presenting a performance study with detailed acceptance criteria and reported device performance.
Therefore, many of the requested sections (1, 2, 3, 4, 5, 6, 7, 8, 9) cannot be fully populated as the document does not describe a performance study in the way a typical AI/software device submission would.
Here's the information that can be extracted or reasonably inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of acceptance criteria and reported device performance in the context of a clinical or analytical performance study, as it is a 510(k) submission for a non-AI, non-software medical device. The "acceptance criteria" here relate to demonstrating substantial equivalence based on product characteristics and biocompatibility.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance / Compliance |
|---|---|---|
| Intended Use | Umbilical cord blood sampling and transfer. Single use. | Device is used for umbilical cord blood sampling and transfer, and is for single use only. (Matches predicate) |
| Technological Characteristics | Single-use device. Empty cup with attached needle assembly accessible to a blood collection tube. Used to collect and transfer umbilical cord blood. | Device is single-use, consists of a cup with an Angel Wing Transfer device for blood transfer. Functions similarly to predicate. (Matches predicate) |
| Biocompatibility | Meets requirements of ISO 10993, Part 1, with FDA modified matrix G95-1. | Biocompatibility testing demonstrated compliance with ISO 10993, Part 1, and FDA modified matrix G95-1. (Meets standard) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission describes an inert device for blood collection and focuses on substantial equivalence and biocompatibility, not performance on a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. See point 2.
4. Adjudication Method for the Test Set
Not applicable. See point 2.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/software device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI/software device.
7. The Type of Ground Truth Used
Not applicable in the context of evaluating diagnostic accuracy or a similar performance claim. The "ground truth" for this device relates to its physical and material properties meeting established standards (e.g., biocompatibility standards) and its functional similarity to the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device does not involve a "training set" in the context of machine learning.
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DEC - 8 2003
EXHIBIT # 7
510(k) Summary
In accordance with section 513(!) of the SMDA and as defined in 21 CFR Part 807.3 final in accordantos with 20014, 1994, this summary is submitted by:
The Kendall Company 15 Hampshire Street Mansfield, MA 02048 Date Prepared: August 4, 2003
Contact Person 1.
Gail Christie Manager, Regulatory Affairs (508) 261-8440
Name of Medical Device 2.
Classification Name: Empty Container for the collection and processing of blood and blood components.
Common or Usual Name: Kit, Umbilical Cord Blood Collection
Identification of Legally Marketed Device 3.
The proposed Kendall LifeTrace Umbilical Blood Collection Kit is substantially The proposed Rendall Life Hase Brian and function to the DeRoyal Surgical, Umbilicup 510(k) No. K02753.
Device Description 4.
The Kendall LifeTrace Umbilical Blood Collection Device consists of a cup shaped The Kendan Life Frace Onlined Blood October umbilical cord blood for analysis
body, divided in half. The top half is used to collect umbilical cord blood for used body, divided in half. The top half contains an Angel Wing Transfer device that is used and has a lid. The bottom hall somains an the s. The device is used to facilitate the to paneser of the collected blood from the top chamber to the tube.
Device Intended Use 5.
The device is intended for single use only. The device is used for umbilical cord blood sampling and transfer.
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6. Product Comparison
The proposed device has the same technological characteristics as the predicate devices. The proposed Kendall LifeTrace Umbilical Blood Collection Kit is substantially equivalent to the predicate devices in the following areas:
- Each product is single use. .
- Each product consists of an empty cup with an attached needle . assembly accessible to a blood collection tube.
- Each product is used to collect and transfer umbilical cord blood .
Nonclinical Testing 7.
Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. The overall design is simple and conveys a sense of national identity and governmental authority.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
DEC - 8 2003
Ms. Gail Christie Manager, Scientific Services/Regulatory Affairs Tyco Healthcare 15 Hampshire Street Mansfield, MA 02048
Re: K032827
Trade/Device Name: Kendall LIFETRACE Umbilical Blood Collection Kit Regulation Number: 21 CFR 864. 9100 Regulation Name: Empty container for the collection and processing of blood and blood components Regulatory Class: Class II Product Code: KSR Dated: September 4, 2003 Received: September 10, 2003
Dear Ms. Christie:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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.
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K032827
Device Name: Kendali LIFETRACE Umbilical Blood Collection Kit
Indications for Use:
The device is used for umbilical cord blood sampling and transfer. The device is intended for single use only.
Please Do Not Write Below This Line - Continue On Another Page If Needed
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use __ Use (Per 21 CFR 801.109) OR
Over-The-Counter
14
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K93 2827
§ 864.9100 Empty container for the collection and processing of blood and blood components.
(a)
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.(b)
Classification. Class II (performance standards).