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 Description

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), softwaredriven (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-212032, 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 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.

AI/ML Overview

The provided document describes the REDOX pneumatic compression device and its 소프트웨어 (software) testing. It includes acceptance criteria for the software's performance, details about the testing methodology, and the results obtained.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance and Results
Maintain average pressure within ±15 mmHg of target (pulsation verification)	Pulsation Verification Procedures:- Tested for various pressure settings (140, 160, 180 mmHg), cycle times (20 sec), hold times (1-5 sec) for foot and arm wraps (right, left, and bilateral).- Each setting was tested for 5 consecutive cycles after "ramp-up."- Results: The tables on pages 10-12 show the recorded pressure readings for all tested configurations. For example, at PS 1 (140 mmHg), CT 20, HT 1, the average pressures for the foot wrap (right, left, bilateral) ranged from 131.2 to 143.2 mmHg, and for the arm wrap (right, left, bilateral) ranged from 140.8 to 152 mmHg. All these reported average pressures fall within ±15 mmHg of the target 140 mmHg (i.e., between 125 mmHg and 155 mmHg). Similar checks for PS 3 (160 mmHg target, range 145-175 mmHg) and PS 5 (180 mmHg target, range 165-195 mmHg) show that the reported average pressures generally fall within the specified tolerance.
Activate visual and audio alarms for high pressure	Alarm Testing - High Pressure:- Method: Kinked PVC hose from unit to inflatable wrap.- Results: The table on page 13 indicates "X" for "YES" under "HIGH PRESSURE" for all foot wrap and arm wrap configurations (right, left, bilateral), and for "UNIT MALFUNCTION" scenarios where the hose was removed. This implies the unit successfully alarmed under high-pressure conditions.
Activate visual and audio alarms for low pressure	Alarm Testing - Low Pressure:- Method: Cut an 1/8" slit in the bladder area of the wrap, replaced a good wrap with the cut wrap, and observed if the unit alarmed after 5 consecutive cycles.- Results: The table on page 13 indicates "X" for "YES" under "LOW PRESSURE" for all foot wrap and arm wrap configurations (right, left, bilateral). This implies the unit successfully alarmed under low-pressure conditions.
Activate visual and audio alarms for unit malfunction	Alarm Testing - Unit Malfunction:- Method: Disconnected PVC hose from the unit.- Results: The table on page 13 indicates "X" for "YES" under "LOW PRESSURE" for unit malfunction scenarios (Right Hose Removed, Left Hose Removed, Both Hoses Removed), and also "X" for "YES" under "HIGH PRESSURE" for these scenarios. This suggests that the unit alarms (likely a low-pressure alarm due to hose removal resulting in no pressure or unexpected high pressure due to blocked outflow) correctly for unit malfunction. The text explicitly states "If the unit alarms then the software passes."
Software handles rapid input changes (stress test)	Software Stress Test - Rapid Input:- Method: Rapidly change pulsation setting after the unit has "ramped-up."- Results: The table on page 13 indicates "X" for "PASS" under "RAPID INPUT" for all foot wrap and arm wrap configurations. This means the unit adjusted to the new pulsation setting correctly.
Software handles operational disruptions (stress test)	Software Stress Test - Operational Disrupt:- Method: Change pulsation setting while a wrap is inflated.- Results: The table on page 13 indicates "X" for "PASS" under "OPERATIONAL DISRUPT" for all foot wrap and arm wrap configurations. This means the unit operated at the new pulsation setting on the next cycle, indicating successful handling of the disruption.

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

Sample Size: For pulsation verification, each unique combination of pressure setting (3 levels), hold time (5 levels), and wrap configuration (right foot, left foot, bilateral foot, right arm, left arm, bilateral arm) was tested for 5 consecutive cycles after ramp-up. This amounts to (3 * 5 * 6) = 90 distinct test scenarios, each with 5 data points, or 450 individual pressure readings.
For alarm testing and software stress tests, specific scenarios were performed for each wrap configuration, covering various types of alarm conditions and stress inputs. The exact number of individual successful alarms or operational adjustments is not quantified beyond a 'PASS' mark.
Data Provenance: The data is prospective and generated from internal testing of the device, Unit 61578. The country of origin is not explicitly stated but can be inferred as the United States given the submission to the FDA.

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

Ground truth for this device, a pneumatic compression device, is established by engineering specifications and measurements. The "ground truth" is whether the device accurately maintains pressure, alarms when necessary, and responds correctly to user inputs, as defined by its design specifications.
There were no human experts (like radiologists) used to establish ground truth for this device's software performance, as it's a mechanical/software functional test rather than an interpretive medical imaging test. The testing was performed by "T. Randolph" (likely a test engineer or technician) on Unit 61578.

4. Adjudication Method for the Test Set

None applicable in the typical sense of expert review for diagnostic devices. The acceptance criteria are objective and quantitative (e.g., pressure within ±15 mmHg) or binary (alarm/no alarm, pass/fail for stress tests). The testing procedures directly assess these objective criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The REDOX device is a therapeutic pneumatic compression device, and its safety and effectiveness were evaluated through engineering and software functional testing rather than human interpretation tasks.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

Yes, a standalone performance study was done for the algorithm (software). The entire non-clinical testing described, including pulsation verification, alarm testing, and software stress tests, assesses the device's software and hardware functionalities without human intervention in its operational performance. The results table specifically details the pressure outputs and alarm triggers, demonstrating the algorithm's performance.

7. Type of Ground Truth Used

The ground truth used is based on engineering specifications and measurable physical parameters.
- For pulsation verification: The specified target pressure (e.g., 140 mmHg, 160 mmHg, 180 mmHg) and the ±15 mmHg tolerance range.
- For alarm testing: The expected activation of visual and audio alarms under defined low pressure, high pressure, and unit malfunction conditions.
- For software stress tests: The expected correct adjustment to new settings after rapid input or operational disruptions.

8. Sample Size for the Training Set

The document does not provide details about a training set for the device's software. Given the release date of 1996 and the nature of the device (pneumatic compression), it is highly probable that the software development did not involve what would today be commonly referred to as a "training set" in the context of machine learning. The software likely followed traditional deterministic programming paradigms and was developed based on established control theory and engineering principles.

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

As there's no mention of a "training set" in the context of machine learning, this question is not applicable. The ground truth for the software's functionality was established through engineering design specifications and requirements.

Summary

{0}------------------------------------------------

K9535tC

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: 210/225-7386 210/225-4285 Fax:

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 Y

CONFIDENTIAL

{1}------------------------------------------------

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 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).

{2}------------------------------------------------

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).

{3}------------------------------------------------

Image /page/3/Figure/0 description: The image shows a diagram of a robotic arm control system. The diagram includes components such as manifolds and valves, a pump, a tank, and a microprocessor for feedback control. The robotic arms are labeled as "LEFT" and "RIGHT", and the diagram also indicates connections to the atmosphere, air lines, and electrical lines.

Image /page/3/Figure/1 description: The image shows the text "Figure A.1" vertically oriented. The word "Figure" is stacked on top of "A.1". The text is black and the background is white.

{4}------------------------------------------------

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.

{5}------------------------------------------------

SECTION 807.92 a(6)

TECHNOLOGICAL CHARACTERISTICS:

	PREDICATE DEVICE:	SUBMITTED DEVICE:
	COWBOY X	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	$\pm$ 15 mmHg	Same
User Interface	Yes	Yes
ACCESSORIES:
Foot Wrap	Yes	No
Arm Wrap	No	Yes
Material	Lycra InteriorLoop Exterior	Same
Manufacturing Process	Die CuttingR-F WeldingSewingHot Stamping	Same
Tooling	"T" Shaped	"C" Shaped

: 上一

{6}------------------------------------------------

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 pressurethroughout 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 RED()X 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 allarms. 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 ONI.Y 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
  - Pressure setting at 1. cycle time at 20, and hold time at 4 1.6.3
  - Pressure setting at 1. cycle time at 20, and hold time at 5 1.6.4
  - 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
  - Pressure setting at 3, cycle time at 20, and hold time at 5 1.6.9
  - 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

{7}------------------------------------------------

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
1. 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. cvcle 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 U SE 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

{8}------------------------------------------------

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, cvcle time at 20, and hold time at 1
5.4 From the FOR SERVICE USE ()NLY 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
1. 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. cvcle time at 20, and hold time at I
- 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
1. Low pressure alarm left foot wrap repeat steps 1.1 thru 1.5
1. Low pressure alarm right arm wrap repeat steps 1.1 thru 1.5
1. Low pressure alarm left arm wrap repeat steps 1 1 thru 1.5

{9}------------------------------------------------

1. 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
1. 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
1. 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

{10}------------------------------------------------

SECTION 807.92 b(1) cont

RESULTS OF NONCLINICAL TESTING:

152

AVERAGE

128

148

1 36

148 | | 134.4 | | 145.6 | | |42.4 | | |49.6 | | |47.2 || | |48.4

148

152

148

REDOX and Predicate Device (K944567) Software Testing Performed by T. Randolph Test Unit: 61578 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
	BILATERAL			BILATERAL
	RIGHT	LEFT	RIGHT LEFT	RIGHT	LEFT	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
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
	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
	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
	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
	166.2	152.8	162.2	163.8	167.8	164	164.2	157.8

148

144

{11}------------------------------------------------

		FOOT WRAP				ARM WRAP
	RIGHT	LEFT	BILATERAL		RIGHT	LEFT	BILATERAL
			RIGHT	LEFT			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

{12}------------------------------------------------

AND AND

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

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 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 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

			FOOT WRAP			ARM WRAP
	RIGHT	LEFT	BILATERALRIGHT LEFT	RIGHT	LEFT	BILATERALRIGHT 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

{13}------------------------------------------------

ALARM TESTING:

	LOW PRESSURE		HIGH PRESSURE
	YES	NO	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		OPERATIONAL DISRUPT
	PASS	FAIL	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

{14}------------------------------------------------

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

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
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.(b)
Classification. Class II (performance standards).