To be used with the Haemonetics Cell Saver HaemoLite 2 family of autologous blood recovery systems to collect, concentrate, and wash red blood cells from diluted intraoperative and post-operative shed blood for autotransfusion.

Device Description

This Special 510(k) premarket notification describes a modification to Haemonetics' currently legally marketed autotransfusion disposable set LN163. The modifications are dimensional changes to 1) the centrifugal processing bowl, and the Final Product Bag and Waste Bag incorporated in the LN163 disposable set, and 2) the disposable thermoformed tub used for packaging of the LN163 disposable set. The intended use of the modified disposable set (the "LN193") is the same as for the LN163 disposable set and has not changed as result of the change in centrifugal blood processing bowl. Additionally, the design configuration, material composition, manufacturing methods and operational principles for the LN193 disposable set are equivalent to those of the LN163 disposable set.

AI/ML Overview

Device Acceptance Criteria and Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for the LN193 disposable set. Instead, the primary acceptance criterion is described as "substantial equivalence" to the predicate device (LN163).

However, the summary indicates that "Verification testing has been performed and demonstrated that the performance of the modified LN163 Disposable Set is not adversely affected by the listed changes." This implies that the device successfully met the intended performance standards, which are assumed to be consistent with the predicate device.

Given the information, the table is structured to reflect this focus on substantial equivalence rather than explicit numerical acceptance criteria.

Acceptance Criterion (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device (LN163)	Demonstrated through verification testing; modifications (dimensional changes) do not affect intended use or alter fundamental scientific technology. Device is deemed "substantially equivalent to legally marketed devices."
Performance not adversely affected by dimensional changes	"Verification testing has been performed and demonstrated that the performance of the modified LN163 Disposable Set is not adversely affected by the listed changes."
Intended Use Maintained	The intended use of the LN193 is "the same as for the LN163 disposable set and has not changed as result of the change in centrifugal blood processing bowl."
Equivalent design configuration, material composition, manufacturing methods, and operational principles	"the design configuration, material composition, manufacturing methods and operational principles for the LN193 disposable set are equivalent to those of the LN163 disposable set."
Conformity to Quality System Regulations	Haemonetics operates under a quality system based on FDA's Quality System Regulation, ISO 9001, EN 46001, and Medical Device Directive 93/42/EEC.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any test set. The term "verification testing" is used, but details on the number of units tested, the types of tests performed, or the data collected are not provided.

The data provenance is not explicitly stated. However, given it's a 510(k) submission from Haemonetics Corporation (Braintree, MA, USA), the testing would likely have been conducted in the United States or at facilities overseen by the company. It is a retrospective analysis in the sense that the data being submitted is from testing already completed, though the specific nature of the data (e.g., patient data, lab testing) is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided for this type of device submission. The device is a disposable set for blood processing, not a diagnostic or screening tool requiring expert interpretation of results. The "ground truth" would be established by objective measurements and functional performance tests rather than expert consensus on diagnostic images or clinical findings.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in studies where human interpretation or consensus is required, such as when establishing ground truth for medical imaging analysis. For a manufacturing change to a disposable blood processing set, verification testing would involve objective measurements and comparisons against specifications, not an adjudication process.

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

This information is not applicable and not provided. The device is a disposable set for autotransfusion, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. The device is a physical disposable medical product, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not explicitly define "ground truth" in a way that aligns with typical diagnostic or AI performance studies. For this device, "ground truth" would implicitly refer to the established performance specifications and functional requirements of the predicate device (LN163). The verification testing would have aimed to demonstrate that the modified LN193 met these same objective performance criteria related to:

Red blood cell collection, concentration, and washing efficacy.
Sterility and biocompatibility.
Integrity and function of the physical components (bowl, bags, tubing).
Compatibility with the HaemoLite 2 system.

These would be verified through engineering tests, material compliance, and functional performance assessments, not through expert consensus, pathology, or outcomes data in the typical sense.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in the context of this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reasons as #8.

Summary

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NOV 1 8 1999

510(K) SUMMARY

Date:	October 18, 1999
Sponsor:	Haemonetics Corporation400 Wood RoadBraintree, MA 02184
Contact:	Alicia R. LopezTel: (781) 356-9253Fax: (781) 356-3558
Proprietary Name:	Haemonetics LN193 Disposable Set (210 mL bowl withdiverter), for use with Haemonetics Cell Saver HaemoLite2 family of autologous blood recovery systems
Classification Name:	Empty container for the collection and processing of bloodand blood components (21 CFR 864.9100)
Common Name:	LN193, HaemoLite® Autotransfusion Disposable Set

Predicate Devices:

Predicate Device	Reference
LN 163 – Haemonetics Cell SaverHaemoLite 2 Disposable Set (200 mLbowl with diverter) 6	K883934

DEVICE DESCRIPTION

Modification to an Existing Device

୧ The LN163 Disposable Set for use with the Haemonetics Cell Saver HaemoLite 2 Autologous Blood Recovery System was reviewed by FDA under K883934; the LN163 Disposable Set at that time was referred to as the LN162, and the HaemoLite 2 was referred to as the HaemoLite B.

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Intended Use

Haemonetics LN193 disposable set is to be used with the Haemonetics Cell Saver HaemoLite 2 family of autologous blood recovery systems, to collect, concentrate, and wash red blood cells from diluted intraoperative and post-operative shed blood for autotransfusion.

DESIGN CONTROL ACTIVITIES

For the production, design, manufacturing and worldwide marketing of automated blood processing systems. Haemonetics has established and is operating under a quality system that is based upon the requirements of the US Food and Drug Administration's Quality System Requlation. International Organization for Standardization's ISO 9001. the European Committee for Standardization's EN 46001, and the Medical Device Directive 93/42/EEC.

In accordance with Haemonetics' Quality System, potential risks associated with the planned dimensional changes were identified. Verification testing has been performed and demonstrated that the performance of the modified LN163 Disposable Set is not adversely affected by the listed changes.

CONCLUSION

The LN193 disposable set is substantially equivalent to legally marketed devices. The LN193 disposable set is a modification to Haemonetics' currently marketed LN163 disposable set; the modifications are limited to dimensional changes to the centrifugal blood processing bowl, the Final Product Bag and Waste Bag, and the disposable tyvek tub used for packaging. These changes do not affect the intended use or alter the fundamental scientific technology of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three wavy lines representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 1 8 1999

Ms. Alicia R. Lopez Corporate Vice President and General Counsel HAEMONETICS CORPORATION 400 Wood Road Braintree, Massachusetts 02184-9114

Re : K993581 Autotransfusion Disposables Set Regulatory Class : II (Two) Product Code: CAC October 18, 1999 Dated: Received: October 22, 1999

Dear Ms. Lopez:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Please note: this response to your premarket Federal Register. notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Ms. Alicia R.Lopez

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

C. de Lugo de Los Angeles C.

Celia M. Witten, Ph.D.,M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2.7 Indication for Use Statement

510(k) Number:	Not assigned
Device Name:	Haemonetics LN193 Disposable Set (210 mL bowlwith diverter), for use with Haemonetics Cell SaverHaemoLite 2 family of autologous blood recoverysystems
Indications for Use:	To be used with the Haemonetics Cell SaverHaemoLite 2 family of autologous blood recoverysystems to collect, concentrate, and wash red bloodcells from diluted intraoperative and post-operativeshed blood for autotransfusion.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Over-the-Counter Use

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(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices K 97 三三多 510(k) Number _

Section 2

Regulation Number and Section

§ 868.5830 Autotransfusion apparatus.

(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).