HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET

K953681 · Haemonetics Corp. · LKN · Jun 4, 1996 · GU

Device Facts

• Record ID: K953681
• Device Name: HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET
• Applicant: Haemonetics Corp.
• Product Code: LKN · GU
• Decision Date: Jun 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

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.

Device Story

System performs therapeutic plasma exchange (TPE) via centrifugal blood separation. Input: whole blood from patient. Process: blood pumped into Latham bowl (125 ml or 225 ml); centrifugation separates plasma from cellular components; optical sensors monitor bowl outflow to detect platelet-rich layer (buffy coat). Output: plasma collected in bag; remaining blood components returned to patient. Operation: operator loads disposable set, primes with anticoagulant; system cycles between DRAW and RETURN phases. Secondary access site allows continuous fluid replacement. Used in clinical settings by trained operators. Benefits: enables controlled plasma removal and replacement to manage disease states.

Clinical Evidence

Clinical evaluation included 30 subjects undergoing over 100 TPE procedures following AABB 1993 guidelines. Parameters monitored: vital signs, fluid intake/output, extracorporeal volumes. Blood samples (pre/post/18-30 hours post-procedure) analyzed for platelet counts, LDH, hemoglobin, hematocrit, IgA, IgG, IgM, and haptoglobins. A smaller study was conducted on healthy donors. Results indicated safe and effective performance.

Technological Characteristics

Automated centrifugal blood separator. Components: patient harness, Latham bowl (125 ml or 225 ml), collection harness, 5-liter plasma bag. Sensing: optical sensors for buffy coat detection. Energy: electromechanical pumps and centrifuge. Connectivity: standalone. Sterilization: sterile single-use disposables.

Indications for Use

Indicated for patients requiring therapeutic plasma exchange (TPE) as prescribed by a physician. Applicable to patients requiring removal of plasma and replacement with physician-determined solutions.

Predicate Devices

• COBE Spectra Single Needle Access Accessory System for Therapeutic Plasma Exchange (BK900105)
• COBE Single Needle Access disposable set: Blood Tubing Set, List No. 777000-100 (BK900105)
• COBE Single Needle Access disposable set: Single Needle bag and “Y”, List No. 777000-100 (BK900105)
• COBE Single Needle Access disposable set: Return Flow Control Assembly, List No. P951000-000 (BK900105)

Submission Summary (Full Text)

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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: [phone]
Fax: [phone]

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) |

Revised 510(k) Summary
May 20, 1996
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# 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 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. 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

Revised 510(k) Summary
May 20, 1996
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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 cycles 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 post-procedure LDH levels, pre-, post- and 18 hour-post procedure hemoglobin and hematocrit, platelet counts, LDH, IgA, IgG and IgM levels, and pre- and post-haptoglobins.

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

Revised 510(k) Summary
May 20, 1996
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