(27 days)
Not Found
No
The 510(k) summary describes dimensional changes to a disposable set for an existing autotransfusion system and explicitly states that the design configuration, material composition, manufacturing methods, and operational principles are equivalent to the predicate device. There is no mention of AI or ML in the document.
Yes
The device is described as an "autotransfusion disposable set" used to "collect, concentrate, and wash red blood cells from diluted intraoperative and post-operative shed blood for autotransfusion." Autotransfusion is a medical procedure where a patient's own blood is collected, processed, and reinfused, which directly treats or manages a medical condition by returning red blood cells to the patient. This aligns with the definition of a therapeutic device.
No
The device description indicates it is a disposable set used in autologous blood recovery systems for collecting, concentrating, and washing red blood cells for autotransfusion. This is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a modification to a disposable set, which is a physical component used with a blood recovery system. It describes dimensional changes to physical parts like the processing bowl and bags.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "collect, concentrate, and wash red blood cells from diluted intraoperative and post-operative shed blood for autotransfusion." This describes a process performed on blood outside the body for reinfusion into the same patient. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a disposable set used with a blood recovery system. It involves physical processes like centrifugation and washing. This aligns with blood processing for transfusion, not diagnostic testing.
- Lack of Diagnostic Elements: There is no mention of analyzing blood components for diagnostic purposes, detecting diseases, or providing information about a patient's health status.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely for processing blood for reinfusion.
N/A
Intended Use / Indications for 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.
Product codes
CAC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Verification testing has been performed and demonstrated that the performance of the modified LN163 Disposable Set is not adversely affected by the listed changes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
NOV 1 8 1999
510(K) SUMMARY
| Date: | October 18, 1999 |
|---|---|
| Sponsor: | Haemonetics Corporation |
| 400 Wood Road | |
| Braintree, MA 02184 | |
| Contact: | Alicia R. Lopez |
| Tel: (781) 356-9253 | |
| Fax: (781) 356-3558 | |
| Proprietary Name: | Haemonetics LN193 Disposable Set (210 mL bowl with |
| diverter), for use with Haemonetics Cell Saver HaemoLite | |
| 2 family of autologous blood recovery systems | |
| Classification Name: | Empty container for the collection and processing of blood |
| and blood components (21 CFR 864.9100) | |
| Common Name: | LN193, HaemoLite® Autotransfusion Disposable Set |
Predicate Devices:
| Predicate Device | Reference |
|---|---|
| LN 163 – Haemonetics Cell Saver | |
| HaemoLite 2 Disposable Set (200 mL | |
| bowl with diverter) 6 | K883934 |
DEVICE DESCRIPTION
Modification to an Existing Device
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.
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.
1
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.
ર જ
2
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.
3
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
4
- 2.7 Indication for Use Statement
| 510(k) Number: | Not assigned |
|---|---|
| Device Name: | Haemonetics LN193 Disposable Set (210 mL bowl |
| with diverter), for use with Haemonetics Cell Saver | |
| HaemoLite 2 family of autologous blood recovery | |
| systems | |
| Indications for Use: | 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. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺃﺷﻬﺮ ﺃﻥ ﻳﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ OR Prescription Use (Per 21 CFR 801.109)
Over-the-Counter Use
Cuti
(Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices K 97 三三多 510(k) Number _
Section 2