REDOX

K953850 · Kinetic Concepts, Inc. · JOW · Mar 4, 1996 · Cardiovascular

Device Facts

• Record ID: K953850
• Device Name: REDOX
• Applicant: Kinetic Concepts, Inc.
• Product Code: JOW · Cardiovascular
• Decision Date: Mar 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The REDOX pump is indicated for patients who would benefit from a pneumatic compression device applied to the arm. Such benefits include helping to: Prevent Deep Venous Thrombosis (DVT) Prevent venous stasis in the upper extremities Enhance arterial circulation in the upper extremities Reduce post-operative pain and swelling in the upper extremities. Reduce edema in the upper extremities. Reduce wound healing time in the upper extremities Treat and assist healing of cutaneous ulceration in the upper extremities. Reduce compartmental pressures in the upper extremities. Reduce the need for anticoagulant medications prescribed for the prevention of DVT.

Device Story

REDOX is an intermittent pneumatic compression device for hospital use; aids blood circulation in upper extremities. System consists of a reusable microprocessor-controlled pump unit and single-patient use inflatable arm wraps. User selects pressure (140-180 mmHg), cycle time (20-60s), and hold time (1-5s) via membrane switch. Microprocessor monitors wrap pressure, adjusting airflow per cycle to maintain target pressure; triggers visual/audio alarms for high/low pressure or malfunctions. Device helps prevent DVT, reduce edema, and assist wound healing. Clinicians operate the device; output is mechanical compression of veins. Benefits include reduced post-operative pain/swelling and potential reduction in anticoagulant medication needs.

Clinical Evidence

Bench testing only. No clinical data. Testing included pulsation verification across various pressure/cycle/hold settings, alarm functionality (high/low pressure, malfunction), and software stress testing (rapid input, operational disruption). Results demonstrated the device maintains target pressure within ±15 mmHg and successfully triggers alarms under fault conditions.

Technological Characteristics

Portable unit with ABS shell. Microprocessor-controlled pneumatic pump. Power: 115 VAC, 60Hz. Pressure range: 140-180 mmHg. Cycle time: 20-60s. Hold time: 1-5s. Accessories: RF-welded, single-patient use inflatable arm wraps. Software: C-language program. Connectivity: None. Sterilization: Non-sterile.

Indications for Use

Indicated for patients requiring pneumatic compression of the arm to prevent DVT, venous stasis, or edema; enhance circulation; reduce post-op pain/swelling; improve wound healing; or reduce compartmental pressures. Contraindicated in patients with congestive heart failure or suspected pre-existing DVT.

Regulatory Classification

Identification

A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.

Predicate Devices

• COWBOY X (K944567)

Submission Summary (Full Text)

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K 9535000
MAR - 4 1996

# "510(K) SUMMARY"

(Sec. 807.92 Content and format of a 510(k) summary)

## SECTION 807.92 a(1)

**SUBMITTER'S NAME:** KCI New Technologies Inc.

**ADDRESS:** 12922 Flagship
San Antonio, Texas 78247

**CONTACT PERSON:** William H Quirk
Director of Regulatory Affairs
P.O. Box 659508
San Antonio, Texas 78265

**DATE:** August 18, 1995

**PHONE AND FAX:** Tel: [phone]
Fax: [phone]

## SECTION 807.92 a(2)

**DEVICE NAME:** REDOX

**TRADE NAME:** Undetermined

**COMMON NAME:** Pneumatic Compression Device

**CLASSIFICATION NAME:** Compressible Limb Sleeve

## SECTION 807.92 a(3)

**PREDICATE DEVICE**
**CLAIMING EQUIVALENCE**
**TO:** COWBOY X


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2

# SECTION 807.92 a(4)

## DEVICE DESCRIPTION:

*(Please note the controller device is the same controller used for the predicate device.)*

The following device description is per section 3 of the draft “REVIEWER GUIDANCE FOR PREMARKET NOTIFICATION SUBMISSIONS,” dated November, 1993, from the Anesthesiology and Respiratory Devices Branch and the Division of Cardiovascular, Respiratory, and Neurological Devices

The REDOX functions as an intermittent pneumatic compression device that aids in the circulation of blood in patients with lymphedema due to mastectomy, surgery, injury or disease. The REDOX is not a life-supporting or life-sustaining device. Also, the REDOX is not an implant (short-term or long-term), nor is it a sterile device. The REDOX is an electrically-operated (see electrical testing in test section), software-driven (see software testing in test section), prescription device (see drawing A-205360 in labeling section), which is used in a hospital environment (see mechanical testing in test section). The REDOX is comprised of two major components -- the reusable pump unit (controller device) (see drawings C-205303, D-205306, D-212032, D-235308 in engineering drawings section) and a single-patient use inflatable wrap (see drawings D-410009, D-410008, in engineering drawings section). Neither component contains a drug nor biological product as a subcomponent.

The REDOX unit uses a 16’ hospital grade power cord (see drawing B-205337 in engineering drawings section) to supply a voltage of 115 VAC at a frequency of 60Hz with a maximum current consumption of 0.33 amperes and a maximum electrical leakage of less than 100 microamps (see electrical testing in test section) from its power source. An exterior shell made of ABS material, measuring 12” long by 10 3/4” wide by 7” deep, protects the subcomponents of the REDOX 11 pound unit (see drawings D-205306, D-212032 in engineering drawings section).

The compressor inflates one or more of the wraps in minimum intervals of 10 seconds at a maximum pressure of not more than 180 mmHg (±15 mmHg).

The unit features a microprocessor (see drawing D-210528 in engineering drawings section) that controls the unit’s operation. The user selects: 1) the pressure from 140 to 180 mmHg, in 10 mmHg increments; 2) the cycle time from 20 to 60 seconds, in 10 second increments, and; 3) the hold time from 1 to 5 seconds, in 1 second increments (see software testing in test section). Selections are made by the user interfacing with the membrane switch located on the front of the unit (see drawing C-205315 in engineering drawings section and drawing B-235309 in labeling section). The microprocessor also has detection capabilities to monitor the pressure in the wrap(s), adjusting the in and out flow of air on every cycle, to ensure that the target pressure is consistently maintained. If

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3

# SECTION 807.92 a(4) con.t

for any reason the target pressure cannot be maintained, the microprocessor alarm capabilities will activate both visual and audio alarms (see software testing in test section). These alarm capabilities are built in to detect high pressure, low pressure and/or unit malfunction situations, should they ever occur (see software testing in test section).

The non-sterile inflatable wraps are for single patient use only (see labeling section). Arm wraps (see drawings D-410009, D-410008, in engineering drawings section) are designed to fit around and compress the veins in the arm, including both collateral veins and deep veins. Hook-and-loop fasteners are used to hold the wrap comfortably around the arm. The wraps are RF-welded to create an air chamber that can then be inflated by the REDOX unit. This air chamber is what actually applies pressure against the body.

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Figure A.1

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5

# SECTION 807.92 a(5)

## INTENDED USE:

### MEDICAL INDICATIONS:

The REDOX pump is indicated for patients who would benefit from a pneumatic compression device applied to the arm. Such benefits include helping to:

- Prevent Deep Venous Thrombosis (DVT)
- Prevent venous stasis in the upper extremities
- Enhance arterial circulation in the upper extremities
- Reduce post-operative pain and swelling in the upper extremities.
- Reduce edema in the upper extremities.
- Reduce wound healing time in the upper extremities
- Treat and assist healing of cutaneous ulceration in the upper extremities.
- Reduce compartmental pressures in the upper extremities.
- Reduce the need for anticoagulant medications prescribed for the prevention of DVT.

### MEDICAL CONTRAINDICATIONS:

Patient conditions for which the REDOX pump is contraindicated include:

- Presumptive evidence of congestive heart failure
- Suspected pre-existing DVT.

## DIFFERENCES IN INDICATIONS:

The indications for the REDOX are the same as those for the predicate device. The only difference being application to the upper extremity versus the lower extremity.

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SECTION 807.92 a(6)

TECHNOLOGICAL CHARACTERISTICS:

| | PREDICATE DEVICE: COWBOY X | SUBMITTED DEVICE: REDOX |
| --- | --- | --- |
| MAIN UNIT: | | |
| Structural Design | Portable | Same |
| Material | ABS, Aluminum | Same |
| Internal Components | Pump. Tank.
Solenoid Valves | Same |
| Power Supply | 115 VAC 60Hz .33 Amp. | Same |
| Electronics | Microprocessor | Same |
| Software | “C” Language Program | Same |
| OPERATION: | | |
| Cycle Time | 20-60 sec.
(10 sec. increments) | Same |
| Hold Time | 1-5 sec.
(1 sec. increments) | Same |
| Pressure Settings | 140-180 mmHg
(10 mmHg increments) | Same |
| Pressure Readings | ±15 mmHg | Same |
| User Interface | Yes | Yes |
| ACCESSORIES: | | |
| Foot Wrap | Yes | No |
| Arm Wrap | No | Yes |
| Material | Lycra Interior
Loop Exterior | Same |
| Manufacturing Process | Die Cutting
R-F Welding
Sewing
Hot Stamping | Same |
| Tooling | “T” Shaped | “C” Shaped |

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7

# SECTION 807.92 b(1)

## DISCUSSION OF NONCLINICAL TESTING:

### SOFTWARE TEST PROTOCOL AND PROCEDURES

The test protocol for the REDOX is very simple. The REDOX software will pass if it can operate within specifications. These specifications include being able to maintain an average pressure in the inflatable wrap(s) within ±15 mmHg of target pressure throughout the entire hold time and setting off visual and audio alarms in the event of a high pressure, low pressure, and/or unit malfunction. If for any reason any one of these specifications are not met, the software is rejected.

The software test procedures for the REDOX have been designed to take advantage of our experience with the predicate device. First, we will focus on pulsation settings that will give the system the least amount of time to recover. Second, we will focus on low pressure, high pressure, and unit malfunction **alarms**. Finally, we will focus on **stressing** the software with rapid input and operational disruptions.

## PULSATION VERIFICATION PROCEDURES

### 1. Right Foot Wrap

1.1 Test pressure at the wrap per operation and maintenance manual page 6-2
1.2 Wrap foot wrap around a simulated foot model
1.3 Set pulsation settings at pressure setting 1, cycle time at 20, and hold time at 1
1.4 From the FOR SERVICE USE ONLY screen press VIEW then press HOME
1.5 Under RS write down the pressure reading shown on the screen for five consecutive cycles after the unit has “Ramped-up”
1.6 Repeat process for:

1.6.1 Pressure setting at 1, cycle time at 20, and hold time at 2
1.6.2 Pressure setting at 1, cycle time at 20, and hold time at 3
1.6.3 Pressure setting at 1, cycle time at 20, and hold time at 4
1.6.4 Pressure setting at 1, cycle time at 20, and hold time at 5
1.6.5 Pressure setting at 3, cycle time at 20, and hold time at 1
1.6.6 Pressure setting at 3, cycle time at 20, and hold time at 2
1.6.7 Pressure setting at 3, cycle time at 20, and hold time at 3
1.6.8 Pressure setting at 3, cycle time at 20, and hold time at 4
1.6.9 Pressure setting at 3, cycle time at 20, and hold time at 5
1.6.10 Pressure setting at 5, cycle time at 20, and hold time at 1
1.6.11 Pressure setting at 5, cycle time at 20, and hold time at 2

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# SECTION 807.92 b(1) cont

1.6.12 Pressure setting at 5, cycle time at 20, and hold time at 3
1.6.13 Pressure setting at 5, cycle time at 20, and hold time at 4
1.6.14 Pressure setting at 5, cycle time at 20, and hold time at 5

## 2. Left Foot Wrap

2.1 Test pressure at the wrap per operation and maintenance manual page 6-2
2.2 Wrap foot wrap around a simulated foot model
2.3 Set pulsation settings at pressure setting 1, cycle time at 20, and hold time at 1
2.4 From the FOR SERVICE USE ONLY screen press VIEW then press HOME
2.5 Under LS write down the pressure reading shown on the screen for five consecutive cycles after the unit has “Ramped-up”
2.6 Repeat process for same pulsation settings described in steps 1.6.1 thru 1.6.14

## 3. Left & Right Foot Wrap

3.1 Test pressure at the wrap per operation and maintenance manual page 6-2
3.2 Wrap foot wraps around simulated foot models
3.3 Set pulsation settings at pressure setting 1, cycle time at 20, and hold time at 1
3.4 From the FOR SERVICE USE ONLY screen press VIEW then press HOME
3.5 Under RS and LS write down the pressure reading shown on the screen for five consecutive cycles after the unit has “Ramped-up”
3.6 Repeat process for same pulsation settings described in steps 1.6.1 thru 1.6.14

## 4. Right Arm Wrap

4.1 Test pressure at the wrap per operation and maintenance manual page 6-2
4.2 Wrap arm wrap around a simulated arm model
4.3 Set pulsation settings at pressure setting 1, cycle time at 20, and hold time at 1
4.4 From the FOR SERVICE USE ONLY screen press VIEW then press HOME
4.5 Under RS write down the pressure reading shown on the screen for five consecutive cycles after the unit has “Ramped-up”
4.6 Repeat process for same pulsation settings described in steps 1.6.1 thru 1.6.14

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# SECTION 807.92 b(1) cont

## 5. Left Arm Wrap

5.1 Test pressure at the wrap per operation and maintenance manual page 6-2
5.2 Wrap arm wrap around a simulated arm model
5.3 Set pulsation settings at pressure setting 1, cycle time at 20, and hold time at 1
5.4 From the FOR SERVICE USE ONLY screen press VIEW then press HOME
5.5 Under LS write down the pressure reading shown on the screen for five consecutive cycles after the unit has “Ramped-up”
5.6 Repeat process for same pulsation settings described in steps 1.6.1 thru 1.6.14

## 6. Left & Right Arm Wrap

6.1 Test pressure at the wrap per operation and maintenance manual page 6-2
6.2 Wrap arm wraps around simulated arm models
6.3 Set pulsation settings at pressure setting 1, cycle time at 20, and hold time at 1
6.4 From the FOR SERVICE USE ONLY screen press VIEW then press HOME
6.5 Under RS and LS write down the pressure reading shown on the screen for five consecutive cycles after the unit has “Ramped-up”
6.6 Repeat process for same pulsation settings described in steps 1.6.1 thru 1.6.14

## ALARM TESTING PROCEDURE

1. Low pressure alarm right foot wrap
1.1 With scissors cut a 1/8” slit in the bladder area of the wrap
1.2 With a good inflatable wrap allow the unit to “ramp-up” at pressure setting 1, cycle time 20, and hold time 1
1.3 Replace the good inflatable wrap with the inflatable wrap in step 1.1
1.4 If after 5 consecutive cycles the unit alarms then the software passes. Otherwise the software fails

2. Low pressure alarm left foot wrap repeat steps 1.1 thru 1.5

3. Low pressure alarm right arm wrap repeat steps 1.1 thru 1.5

4. Low pressure alarm left arm wrap repeat steps 1.1 thru 1.5

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5. High pressure alarm right foot wrap
5.1 Kink PVC hose from the unit to the inflatable wrap
5.2 If after 5 consecutive cycles the unit alarms then the software passes. Otherwise the software fails
5.3 Repeat steps 6.1 and 6.2 for all possible inflatable wrap combinations

6. Unit malfunction
6.1 Disconnect PVC hose from unit
6.2 If the unit alarms then the software passes. Otherwise the software fails

## SOFTWARE STRESS TEST:

1. Rapid input
1.1 Select any pulsation setting
1.2 Allow the unit to “ramp-up”
1.3 Now rapidly change pulsation setting. If the unit adjusts to the new pulsation setting then the software passes. Otherwise the software fails
1.4 Repeat steps 1.1 thru 1.3 for right and left foot and arm wraps

2. Operational disrupt
2.1 Select any pulsation setting
2.2 Allow the unit to “ramp-up”
2.3 Now while a wrap is inflated, change the pulsation setting. If on the next cycle the unit operates at the new pulsation setting the software passes. Otherwise the software fails
2.4 Repeat steps 2.1 thru 2.3 for right and left foot and arm wraps

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# SECTION 807.92 b(1) cont

## RESULTS OF NONCLINICAL TESTING:

REDOX and Predicate Device (K944567) Software Testing

Test Unit: 61578 Performed by T. Randolph Date: 8/2/95

Accessories Wrapped Around High Density Foam

Pressure Settings (PS)(1=140 mmHg, 3=160mmHg, 5=180mmHg)

Cycle Time (CT) (sec.) Hold Time (HT) (sec.)

| | FOOT WRAP | | | | ARM WRAP | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | RIGHT | LEFT | BILATERAL RIGHT LEFT | | RIGHT | LEFT | BILATERAL RIGHT LEFT | |
| PS 1, CT 20, HT 1 | 144 | 132 | 144 | 144 | 152 | 152 | 148 | 136 |
| | 140 | 132 | 144 | 140 | 152 | 144 | 144 | 144 |
| | 144 | 132 | 140 | 140 | 152 | 136 | 148 | 144 |
| | 144 | 132 | 140 | 140 | 152 | 140 | 140 | 144 |
| | 144 | 128 | 140 | 140 | 152 | 140 | 144 | 136 |
| AVERAGE | 143.2 | 131.2 | 141.6 | 140.8 | 152 | 142.4 | 144.8 | 140.8 |
| PS 1, CT 20, HT 2 | 148 | 124 | 144 | 140 | 152 | 144 | 148 | 140 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 148 | 136 | 144 | 140 | 156 | 144 | 156 | 140 |
| | 148 | 132 | 144 | 132 | 156 | 148 | 148 | 140 |
| | 148 | 132 | 152 | 140 | 156 | 148 | 148 | 144 |
| | 144 | 132 | 144 | 140 | 152 | 148 | 148 | 144 |
| AVERAGE | 147.2 | 131.2 | 145.6 | 138.4 | 154.4 | 146.4 | 149.6 | 141.6 |
| PS 1, CT 20, HT 3 | 144 | 132 | 148 | 132 | 156 | 152 | 148 | 144 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 140 | 132 | 144 | 140 | 148 | 140 | 148 | 144 |
| | 144 | 132 | 144 | 144 | 148 | 144 | 148 | 144 |
| | 144 | 132 | 144 | 132 | 148 | 140 | 148 | 152 |
| | 148 | 132 | 144 | 144 | 148 | 144 | 152 | 144 |
| AVERAGE | 144 | 132 | 144.8 | 138.4 | 149.6 | 144 | 148.8 | 145.6 |
| PS 1, CT 20, HT 4 | 140 | 140 | 148 | 144 | 148 | 140 | 144 | 140 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 144 | 128 | 148 | 144 | 156 | 140 | 140 | 144 |
| | 148 | 124 | 148 | 144 | 152 | 140 | 152 | 140 |
| | 148 | 128 | 144 | 144 | 156 | 140 | 148 | 148 |
| | 152 | 144 | 144 | 144 | 148 | 140 | 148 | 148 |
| AVERAGE | 146.4 | 132.8 | 146.4 | 144 | 152 | 140 | 146.4 | 144 |
| PS 1, CT 20, HT 5 | 144 | 144 | 144 | 144 | 148 | 152 | 148 | 140 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 144 | 144 | 144 | 144 | 152 | 152 | 152 | 144 |
| | 152 | 128 | 144 | 144 | 144 | 140 | 144 | 140 |
| | 148 | 128 | 148 | 144 | 156 | 140 | 148 | 148 |
| | 152 | 128 | 148 | 136 | 148 | 152 | 148 | 148 |
| AVERAGE | 148 | 134.4 | 145.6 | 142.4 | 149.6 | 147.2 | 148 | 144 |

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| | FOOT WRAP | | | | ARM WRAP | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | RIGHT | LEFT | BILATERAL RIGHT LEFT | | RIGHT | LEFT | BILATERAL RIGHT LEFT | |
| PS 3, CT 20, HT 1 | 163 | 152 | 163 | 167 | 163 | 167 | 171 | 163 |
| | 156 | 148 | 156 | 156 | 171 | 167 | 171 | 163 |
| | 163 | 156 | 156 | 159 | 171 | 171 | 171 | 163 |
| | 159 | 148 | 148 | 159 | 167 | 167 | 167 | 159 |
| | 159 | 144 | 163 | 159 | 167 | 156 | 171 | 167 |
| AVERAGE | 160 | 149.6 | 157.2 | 160 | 167.8 | 165.6 | 170.2 | 163 |
| PS 3, CT 20, HT 2 | 167 | 152 | 159 | 159 | 175 | 167 | 167 | 163 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 167 | 152 | 163 | 163 | 171 | 167 | 163 | 167 |
| | 167 | 152 | 159 | 163 | 171 | 167 | 167 | 167 |
| | 167 | 152 | 163 | 163 | 171 | 167 | 171 | 167 |
| | 167 | 152 | 159 | 163 | 171 | 159 | 167 | 171 |
| AVERAGE | 167 | 152 | 160.6 | 162.2 | 171.8 | 165.4 | 167 | 167 |
| PS 3, CT 20, HT 3 | 167 | 152 | 167 | 171 | 171 | 171 | 163 | 167 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 167 | 148 | 171 | 163 | 167 | 163 | 163 | 163 |
| | 171 | 148 | 163 | 163 | 167 | 167 | 167 | 167 |
| | 167 | 152 | 159 | 163 | 167 | 171 | 163 | 167 |
| | 167 | 152 | 163 | 163 | 167 | 171 | 171 | 163 |
| AVERAGE | 167.8 | 150.4 | 164.6 | 164.6 | 167.8 | 168.6 | 165.4 | 165.4 |
| PS 3, CT 20, HT 4 | 167 | 152 | 159 | 163 | 167 | 171 | 163 | 167 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 171 | 152 | 163 | 163 | 171 | 171 | 171 | 152 |
| | 171 | 152 | 163 | 163 | 167 | 171 | 167 | 167 |
| | 167 | 152 | 163 | 163 | 167 | 163 | 171 | 152 |
| | 171 | 152 | 163 | 163 | 167 | 163 | 167 | 159 |
| AVERAGE | 169.4 | 152 | 162.2 | 163 | 167.8 | 167.8 | 167.8 | 159.4 |
| PS 3, CT 20, HT 5 | 163 | 156 | 159 | 167 | 167 | 163 | 167 | 163 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 167 | 152 | 163 | 163 | 167 | 163 | 171 | 163 |
| | 167 | 152 | 163 | 163 | 167 | 167 | 171 | 163 |
| | 171 | 152 | 163 | 163 | 171 | 171 | 156 | 152 |
| | 163 | 152 | 163 | 163 | 167 | 156 | 156 | 148 |
| AVERAGE | 166.2 | 152.8 | 162.2 | 163.8 | 167.8 | 164 | 164.2 | 157.8 |

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| | FOOT WRAP | | | | ARM WRAP | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | RIGHT | LEFT | BILATERAL RIGHT LEFT | | RIGHT | LEFT | BILATERAL RIGHT LEFT | |
| PS 5, CT 20, HT 1 | 187 | 179 | 187 | 175 | 191 | 183 | 179 | 183 |
| | 187 | 183 | 179 | 175 | 187 | 175 | 187 | 179 |
| | 187 | 183 | 183 | 175 | 191 | 187 | 179 | 187 |
| | 179 | 183 | 179 | 175 | 187 | 187 | 187 | 183 |
| | 187 | 187 | 179 | 167 | 187 | 183 | 179 | 179 |
| AVERAGE | 185.4 | 183 | 181.4 | 173.4 | 188.6 | 183 | 182.2 | 182.2 |
| PS 5, CT 20, HT 2 | 191 | 191 | 183 | 175 | 187 | 191 | 191 | 179 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 191 | 187 | 191 | 179 | 187 | 183 | 175 | 179 |
| | 191 | 183 | 183 | 179 | 191 | 191 | 187 | 179 |
| | 191 | 183 | 187 | 179 | 187 | 183 | 191 | 187 |
| | 191 | 179 | 183 | 179 | 187 | 183 | 191 | 187 |
| AVERAGE | 191 | 184.6 | 185.4 | 178.2 | 187.8 | 186.2 | 187 | 182.2 |
| PS 5, CT 20, HT 3 | 191 | 191 | 191 | 183 | 187 | 179 | 187 | 175 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 191 | 191 | 183 | 167 | 187 | 183 | 191 | 179 |
| | 187 | 191 | 187 | 183 | 187 | 183 | 191 | 179 |
| | 191 | 179 | 183 | 183 | 187 | 183 | 191 | 179 |
| | 191 | 179 | 183 | 187 | 187 | 179 | 191 | 179 |
| AVERAGE | 190.2 | 186.2 | 185.4 | 180.6 | 187 | 181.4 | 190.2 | 178.2 |
| PS 5, CT 20, HT 4 | 191 | 191 | 183 | 187 | 187 | 179 | 187 | 171 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 191 | 179 | 183 | 187 | 187 | 183 | 187 | 175 |
| | 191 | 175 | 183 | 175 | 187 | 183 | 187 | 191 |
| | 191 | 167 | 187 | 179 | 187 | 183 | 187 | 171 |
| | 191 | 175 | 187 | 175 | 187 | 183 | 191 | 187 |
| AVERAGE | 191 | 177.4 | 184.6 | 180.6 | 187 | 182.2 | 187.8 | 179 |
| PS 5, CT 20, HT 5 | 191 | 175 | 187 | 183 | 187 | 175 | 187 | 175 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 187 | 187 | 187 | 175 | 187 | 179 | 187 | 191 |
| | 191 | 187 | 191 | 187 | 187 | 175 | 191 | 191 |
| | 187 | 183 | 183 | 179 | 187 | 183 | 179 | 191 |
| | 187 | 187 | 191 | 175 | 191 | 183 | 191 | 187 |
| AVERAGE | 188.6 | 183.8 | 187.8 | 179.8 | 187.8 | 179 | 187 | 187 |

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ALARM TESTING:

| | LOW PRESSURE
YES NO | | HIGH PRESSURE
YES NO | |
| --- | --- | --- | --- | --- |
| FOOT WRAPS: | | | | |
| Right Only | X | | X | |
| Left Only | X | | X | |
| Bilateral: Right | X | | X | |
| Left | X | | X | |
| | | | | |
| ARM WRAPS: | | | | |
| Right Only | X | | X | |
| Left Only | X | | X | |
| Bilateral: Right | X | | X | |
| Left | X | | X | |
| | | | | |
| UNIT MALFUNCTION: | | | | |
| Right Hose Removed | X | | X | |
| Left Hose Removed | X | | X | |
| Both Hoses Removed | X | | X | |

SOFTWARE STRESS TEST:

| | RAPID INPUT
PASS FAIL: | | OPERATIONAL DISRUPT
PASS FAIL | |
| --- | --- | --- | --- | --- |
| FOOT WRAPS: | | | | |
| Right Only | X | | X | |
| Left Only | X | | X | |
| Bilateral: Right | X | | X | |
| Left | X | | X | |
| | | | | |
| ARM WRAPS: | | | | |
| Right Only | X | | X | |
| Left Only | X | | X | |
| Bilateral: Right | X | | X | |
| Left | X | | X | |

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SECTION 807.92 b(3)

# CONCLUSIONS:

The conclusion that follows is based on section 807.92 a(4) "DEVICE DESCRIPTION" pages 1-3, section 807.92 a(5) "INTENDED USE" pages 3-4, section 807.92 a(6) "TECHNOLOGICAL CHARACTERISTICS" pages 4-5, and section 807.92 b(1) "NONCLINICAL TEST AND RESULTS" pages 5-12 of the "510(K) SUMMARY".

The REDOX and the predicate device both employ the same reusable pump unit (controller), including the same electronics and software. The only difference in the REDOX and the predicate device is the inflatable wrap, which is intended for single patient use. The difference is limited to the general shape of the wrap and the location where the wrap is to be used. There has been no change in the function (squeezing the veins) of the wrap. The REDOX wrap simply squeezes the veins in the arm where the predicate wrap squeezes the veins in the foot.

The reusable pump unit of REDOX and the predicate device are the same. Therefore, the structural design, materials, internal components, power supply, electronics, and software are the same. Also, the operation of the unit is the same. This includes the cycle time, hold time, pressure settings, and user interface. The single patient use, inflatable wrap is different; however, the same material and manufacturing processes are used. Therefore, the technological characteristics of REDOX and the predicate device are the same.

Both the REDOX and the predicate device used the same reusable pump unit for the nonclinical testing. Using the same protocol and procedures, there was no statistical difference in the pulsation verification testing. Also, the alarm and software stress testing yielded identical results. Therefore, the nonclinical tests and results were the same.

The conclusions drawn from the nonclinical testing is that the device is safe, effective, and performs as well as the legally marketed predicate device.

CONFIDENTIAL
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