Predicate Devices

BK900105

Reference Devices

BK900027, BK930013

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard apheresis system with electromechanical components and disposable sets, with no mention of AI or ML capabilities.

Therapeutic

Yes
The intended use explicitly states "TPE is performed using the Haemonetics MCS/MCS+ system to remove a significant quantity of platelet poor plasma and replace it with a solution as determined by the attending physician," which describes a therapeutic intervention. Furthermore, the disposable sets are named "Therapeutic Plasma Exchange Set".

Diagnostic

No

This device is used for therapeutic plasma exchange (TPE), a treatment procedure, rather than for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions physical components like pumps, centrifuge, electromechanical systems, donor safety monitoring systems, and sterile single-use disposable sets, indicating it is a hardware-based system with associated software, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to perform Therapeutic Plasma Exchange (TPE) by removing plasma and replacing it with a solution. This is a therapeutic procedure performed on a patient, not a test performed on a sample in vitro (outside the body) to diagnose a condition.
Device Description: The device description details a system for blood separation and collection, including pumps, a centrifuge, and disposable sets for patient connection and plasma collection. These are components used in a therapeutic procedure.
Lack of IVD Characteristics: There is no mention of analyzing biological samples for diagnostic purposes, detecting specific analytes, or providing information for diagnosis, monitoring, or screening.

The device is a therapeutic apheresis system used for a medical procedure, not a diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

TPE is performed using the Haemonetics MCS/MCS+ system to remove a significant quantity of platelet poor plasma and replace it with a solution as determined by the attending physician.

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

Equipment

The MCS and MCS+ systems have not been physically modified in any significant manner from the systems reviewed by the FDA under 510(k) BK900027 and BK930013. respectively. relative to standard pumps, centrifuge, electromechanical systems and donor safety monitoring systems.

Sterile Single-Use Disposable Sets

List No. 780 Therapeutic Plasma Exchange Set (225 ml Latham bowl) Consists of a patient harness, a 225 ml centrifuge blood separation chamber (Latham bowl) and a collection harness (tubing distal to bowl) all of which are connected during the manufacturing process. A detached 5 liter plasma bag is also included. This disposable set is for use with the MCS+ (List Nos. 7000 and 8100).
List No. 781 Therapeutic Plasma Exchange Set (125 ml Latham bowl) Consists of a patient harness, a 125 ml centrifuqe blood separation chamber (Latham bowl) and a collection harness (tubing distal to bowl) all of which are connected during the manufacturing process. A detached 5 liter plasma bag is also included. This disposable set is for use with the MCS+ (List Nos. 7000 and 8100).
List No. 980 Therapeutic Plasma Exchange Set (225 ml Latham bowl) Consists of a patient harness, a 225 ml centrifuge blood separation chamber (Latham bowl) and a collection harness (tubing distal to bowl) all of which are connected during the manufacturing process. A detached 5 liter plasma bag is also included. This disposable set is for use with the MCS+ (List No. 9000).
List No. 981 Therapeutic Plasma Exchange Set (125 ml Latham bowl) Consists of a patient harness, a 125 ml centrifuge blood separation chamber (Latham bowl) and a collection harness (tubing distal to bowl) all of which are connected during the manufacturing process. A detached 5 liter plasma bag is also included. This disposable set is for use with the MCS+ (List No. 9000).

Operating Protocol Summary

The MCS and MCS+ systems and associated disposable sets are used to perform therapeutic plasma exchange ("TPE") as briefly summarized below.

Protocol options. There are four TPE disposable options which are available: List Nos. 780 and 980 have a 225 ml Latham bowl and List Nos. 781 and 981 have a 125 ml Latham bowl. The smaller bowl size is used when the attending physician desires to minimize the total extracorporeal blood volume (volume temporarily out of circulation) during each processing cycle. The TPE protocol also accommodates the addition of a secondary access site for separate, continuous fluid replacement.

Preparation. The disposable set is loaded on the MCS or MCS+ system by the operator and primed with anticoagulant. With single access, the replacement fluid bag(s) is/are also spiked. When continuous fluid replacement is desired, replacement fluid is connected to a separate intravenous line and pumped. Thereafter the line is connected to the second lumen of a catheter (if dual-lumen) or to a second access intravenous line for gravity re-infusion.

DRAW/RETURN. Blood is pumped from the patient through the tubing directly into the Latham bowl where the components are separated by centrifugation. The plasma exits the top of the bowl and is directed to the collection bag. The system continuously monitors the outflow of the bowl through optical sensors; when the platelet-rich layer ("buffy coat") is detected, the DRAW phase stops. The blood pump reverses and the RETURN phase begins. The remaining contents of the bowl are returned to the patient with replacement fluid (if not being administered via a secondary access site). When the bowl has emptied, the next DRAW phase begins. The number of DRAW/RETURN cvcles required to complete the procedure depends upon the target volume of plasma to be removed.

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)

Clinical Tests:
Haemonetics sponsored clinical evaluations to perform TPE using the MCS with the associated disposable sets.

Briefly, TPE was performed on 30 subjects for over 100 procedures using the AABB Guidelines for Therapeutic Hemapheresis (1993). Subjects were selected from patients for whom TPE was prescribed by their physician. Although enrolled, three subjects were not included in the data analysis because their status as transplant patients put them outside the disease states described by the protocol. The number of procedures and replacement fluids were at the discretion of the attending physician. Patient vital signs, fluid intake/output and extracorporeal volumes were monitored. Blood samples were collected pre- and post-procedure and 18-30 hours post-procedure for sampling. Parameters measured include pre- and post-therapy platelets counts, pre- and postprocedure LDH levels, pre-, post- and18 hour-post procedure hemoglobin and hematocrit, platelet counts, LDH, IgA, IgG and IgM levels, and pre- and posthaptoglobins.

Additionally, a similar, but smaller study was conducted on healthy donors using the MCS+ (LN9000).

The data indicates that the Haemonetics Therapeutic Plasma Exchange protocol and the associated disposables can be performed safely and effectively.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

BK900105

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

BK900027, BK930013

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

0

K953681

REVISED 510(k) SUMMARY

| Date: | May 20, 1996
JUN - 6 1996 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Haemonetics Corporation
400 Wood Road
Braintree, MA 02184 |
| Contact: | Alicia R. Lopez
Corporate Vice President
Tel: (617) 356-9253
Fax: (617) 356-3558 |
| Proprietary names: | Therapeutic Plasma Exchange (TPE) Protocol
List No. 780 Therapeutic Plasma Exchange Set (225 ml Latham bowl)
for use with the MCS®+ (List Nos. 7000 and 8100)
List No. 781 Therapeutic Plasma Exchange Set (125 ml Latham bowl)
for use with the MCS+ (List Nos. 7000 and 8100)
List No. 980 Therapeutic Plasma Exchange Set (225 ml Latham bowl)
for use with the MCS+ (List No. 9000)
List No. 981 Therapeutic Plasma Exchange Set (125 ml Latham bowl)
for use with the MCS+ (List No. 9000) |
| Classification name: | automated (centrifugal) blood separator |
| Common names: | therapeutic disposable collection sets |

Predicate devices:

Product	Predicate Device
MCS/MCS+
(MCS List No. 7000)
(MCS+ List Nos. 8100 and 9000)	COBE Spectra™
Single Needle Access Accessory System for Therapeutic
Plasma Exchange (BK900105)
List Nos. 780 and 980
Therapeutic Plasma Exchange
Sets (225 ml bowl)	COBE Single Needle Access disposable set:
Blood Tubing Set, List No. 777000-100
Single Needle bag and "Y", List No. 777000-100
Return Flow Control Assembly, List No. P951000-000
(BK900105)
List Nos. 781 and 981
Therapeutic Plasma Exchange
Sets (125 ml bowl)	COBE Single Needle Access disposable set:
Blood Tubing Set, List No. 777000-100
Single Needle bag and "Y", List No. 777000-100
Return Flow Control Assembly, List No. P951000-000
(BK900105)

1

DEVICE DESCRIPTION

Equipment

The MCS and MCS+ systems have not been physically modified in any significant manner from the systems reviewed by the FDA under 510(k) BK900027 and BK930013. respectively. relative to standard pumps, centrifuge, electromechanical systems and donor safety monitoring systems.

Sterile Single-Use Disposable Sets

List No. 780 Therapeutic Plasma Exchange Set (225 ml Latham bowl) Consists of a patient harness, a 225 ml centrifuge blood separation chamber (Latham bowl) and a collection harness (tubing distal to bowl) all of which are connected during the manufacturing process. A detached 5 liter plasma bag is also included. This disposable set is for use with the MCS+ (List Nos. 7000 and 8100).
List No. 781 Therapeutic Plasma Exchange Set (125 ml Latham bowl) Consists of a patient harness, a 125 ml centrifuqe blood separation chamber (Latham bowl) and a collection harness (tubing distal to bowl) all of which are connected during the manufacturing process. A detached 5 liter plasma bag is also included. This disposable set is for use with the MCS+ (List Nos. 7000 and 8100).
List No. 980 Therapeutic Plasma Exchange Set (225 ml Latham bowl) Consists of a patient harness, a 225 ml centrifuge blood separation chamber (Latham bowl) and a collection harness (tubing distal to bowl) all of which are connected during the manufacturing process. A detached 5 liter plasma bag is also included. This disposable set is for use with the MCS+ (List No. 9000).
List No. 981 Therapeutic Plasma Exchange Set (125 ml Latham bowl) Consists of a patient harness, a 125 ml centrifuge blood separation chamber (Latham bowl) and a collection harness (tubing distal to bowl) all of which are connected during the manufacturing process. A detached 5 liter plasma bag is also included. This disposable set is for use with the MCS+ (List No. 9000).

Operating Protocol Summary

The MCS and MCS+ systems and associated disposable sets are used to perform therapeutic plasma exchange ("TPE") as briefly summarized below.

Protocol options. There are four TPE disposable options which are available: List Nos. 780 and 980 have a 225 ml Latham bowl and List Nos. 781 and 981 have a 125 ml Latham bowl. The smaller bowl size is used when the attending physician desires to minimize the total extracorporeal blood volume (volume temporarily out of circulation) during each processing cycle. The TPE protocol also accommodates the addition of a secondary access site for separate, continuous fluid replacement.

Preparation. The disposable set is loaded on the MCS or MCS+ system by the operator and primed with anticoagulant. With single access, the replacement fluid

2

bag(s) is/are also spiked. When continuous fluid replacement is desired, replacement fluid is connected to a separate intravenous line and pumped. Thereafter the line is connected to the second lumen of a catheter (if dual-lumen) or to a second access intravenous line for gravity re-infusion.

DRAW/RETURN. Blood is pumped from the patient through the tubing directly into the Latham bowl where the components are separated by centrifugation. The plasma exits the top of the bowl and is directed to the collection bag. The system continuously monitors the outflow of the bowl through optical sensors; when the platelet-rich layer ("buffy coat") is detected, the DRAW phase stops. The blood pump reverses and the RETURN phase begins. The remaining contents of the bowl are returned to the patient with replacement fluid (if not being administered via a secondary access site). When the bowl has emptied, the next DRAW phase begins. The number of DRAW/RETURN cvcles required to complete the procedure depends upon the target volume of plasma to be removed.

Intended Use

TPE is performed using the Haemonetics MCS/MCS+ system to remove a significant quantity of platelet poor plasma and replace it with a solution as determined by the attending physician.

Clinical Tests

Haemonetics sponsored clinical evaluations to perform TPE using the MCS with the associated disposable sets.

Briefly, TPE was performed on 30 subjects for over 100 procedures using the AABB Guidelines for Therapeutic Hemapheresis (1993). Subjects were selected from patients for whom TPE was prescribed by their physician. Although enrolled, three subjects were not included in the data analysis because their status as transplant patients put them outside the disease states described by the protocol. The number of procedures and replacement fluids were at the discretion of the attending physician. Patient vital signs, fluid intake/output and extracorporeal volumes were monitored. Blood samples were collected pre- and post-procedure and 18-30 hours post-procedure for sampling. Parameters measured include pre- and post-therapy platelets counts, pre- and postprocedure LDH levels, pre-, post- and18 hour-post procedure hemoglobin and hematocrit, platelet counts, LDH, IgA, IgG and IgM levels, and pre- and posthaptoglobins.

Additionally, a similar, but smaller study was conducted on healthy donors using the MCS+ (LN9000).

The data indicates that the Haemonetics Therapeutic Plasma Exchange protocol and the associated disposables can be performed safely and effectively.

Conclusion

TPE performed using the MCS+ system with the associated disposable set is substantially equivalent to TPE as performed using marketed devices.