The NormaTec PCD-T and PCD-B are designed to provide noninvasive air compression therapy for the treatment of lymphedema, venous insufficiency, other edemas, and venous stasis ulceration and to prevent deep venous thrombosis.

They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The devices are powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery.

The NormaTec PCD-T and PCD-B consist of an air compressor unit with a control system, an inflatable "appliance" (arms, legs and hips), plastic air tubing with proprietary connectors for connecting the device to the appliance; and an AC-DC adaptor with power cord.

The inflatable leg and arm "appliances" and the plastic air tubing are of the same general design and constructions as those cleared in the predicate NormaTec PCD (K013436) the materials are identical. The hip appliance is identical to that in NormaTec's Pulse and Pulse Pro massagers cleared in 510(k) K160608 and uses identical materials. Additionally, the air compressor, valve control are similar to the predicate NormaTec PCD (and are identical to the NormaTec's Pulse and Pulse Pro massagers cleared in 510(k) K160608)

The user interface on the PCD-T model is a 4.3"Color TFT Screen with Capacitive Sensor (similar to a Smartphone). The user interface on the PCD-B model is 4.3" Color LCD Screen, with Membrane Keypad with dome switches. There is no difference in function between the two interface technologies, they are just being offered for slight feature differences and user preferences.

AI/ML Overview

The provided document is a 510(k) summary for the NormaTec PCD-T and NormaTec PCD-B devices. This type of regulatory submission seeks to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt (e.g., acceptance criteria for device performance studies, sample sizes for test sets, expert-established ground truth, MRMC studies, standalone performance, training set details) is generally not part of a 510(k) submission unless the device introduces new technology or indications for use that differ significantly from the predicate.

In this specific document, the manufacturer relies on a comparison to a predicate device (NormaTec PCD, K013436) and a reference device (NormaTec Pulse and Pulse Pro, K160608) to establish substantial equivalence. Performance testing mentioned is primarily bench testing and compliance with electrical safety and electromagnetic compatibility standards.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria for device performance studies in the way you might expect for a novel device proving efficacy. Instead, the "performance" is largely demonstrated by showing substantial equivalence to the predicate device and compliance with relevant safety standards.

The closest we get to "reported device performance" in relation to acceptance criteria is the statement under "Performance Testing": "The device has been tested to ensure that it all requirements have been met, this includes:

Testing of all controls
Testing of all indicators
Testing of battery state indicators
Testing of performance
Testing of hazard mitigations"

However, no specific performance metrics (e.g., pressure accuracy, cycle timing accuracy with defined thresholds) or the results against them are provided in this summary. The "acceptance criteria" here implicitly refers to the device functioning as intended and matching the performance characteristics of the predicate, as well as meeting the requirements of the standards listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable/not provided. The performance testing described is bench testing, not a study involving human subjects or collected data sets in the typical sense.
Data Provenance: Not applicable/not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/not provided. "Ground truth" is typically established in clinical or diagnostic studies. For these devices, the "ground truth" for demonstrating substantial equivalence is the predicate device's established safety and performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/not provided. No clinical test set requiring expert adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/not provided. This is not an AI-enabled diagnostic device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/not provided. This is a physical medical device (compressible limb sleeve), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this 510(k) submission, the "ground truth" for regulatory clearance is the substantial equivalence to the predicate device, which has already been deemed safe and effective for its intended uses. The performance testing focuses on ensuring the new device operates similarly and meets safety standards.

8. The sample size for the training set

Not applicable/not provided. This is a physical device, not a machine learning model.

9. How the ground truth for the training set was established

Not applicable/not provided.

Summary of what was included and relevant for a 510(k) submission:

Predicate Device Comparison Table (Pages 7-8): This is the core of the substantial equivalence argument. It directly compares the new devices (PCD-T and PCD-B) to the predicate device (PCD K013436) across several attributes, including:
- Indications for Use (Identical)
- Contraindications (Identical)
- Prescriptive (Identical)
- Power Source (New devices have optional integrated battery)
- Software/Firmware/Microprocessor Control (Same control technology)
- Technology (Identical compressor and valve system)
- Compliance with Voluntary Standards (New devices comply with updated standards and a home use standard)
- Device Pressure range (Identical)
- Treatment Time (New devices have added ability to time treatment)
- Inflation/deflation cycle type (Identical)
- Appliance contact surface material (Identical)
- Number of Inflatable appliance segments (Identical)
- Weight and Dimensions (Similar, new devices are lighter/smaller)
- Housing Materials and Constructions (Similar)
- Patient contact (Identical)
- Appliances (New devices use leg/arm appliances from K013436 and hip appliance from K160608)
Performance Testing (Page 9):
- Bench Testing: Described as ensuring "all requirements have been met," including controls, indicators, battery state, overall performance, and hazard mitigations. No specific quantitative criteria or results are provided in this summary.
- Standards Compliance:
  - AAMI / ANSI ES60601-1:2005 (Medical electrical equipment - basic safety and essential performance)
  - IEC 60601-1-2: 2007 (Electromagnetic Compatibility)
  - IEC 60601-1-11: 2010 (Home healthcare environment)
No Animal Testing or Clinical Testing was performed.

The conclusion explicitly states "The NormaTec PCD-T and PCD-B are substantially equivalent to the predicates in: indications for use, contraindications, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise questions of safety and effectiveness." This statement, along with the detailed comparison table and standards compliance, forms the basis of the "proof" that the device meets the implicit acceptance criteria for a 510(k) clearance.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three overlapping faces. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 15, 2016

NormaTec Industries, LP c/o Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K161346

Trade/Device Name: NormaTec PCD-T and NormaTec PCD-B Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 13, 2016 Received: May 16, 2016

Dear Mark Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Nicole G. Ibrahim -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known)

K161346

Device Name

NormaTec PCD-T and NormaTec PCD-B

Indications for Use (Describe)

The NormaTec PCD-T and NormaTec PCD-B are intended to apply pressure to the extremities to treat:

Lymphedema and other edematous conditions, including

Congenital lymphedema (Millroy's disease, lymphedema praecox, ●
and lymphedema tarda) ●
Post-mastectomy lymphedema
Post-infection lymphedema ●
Post-traumatic lymphedema .
. Post-surgical lymphedema
Post-radiation-treatment lymphedema .
Venous insufficiency .
Venous stasis ulceration ●

and to prevent:

Deep Vein Thrombosis

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Official Address:	NormaTec Industries, LP44 Glen AveNewton, MA 02459Tel - 617 658 5827 Fax - 617 928 3407
Official Contact:	Peter Novello – Director Manufacturing and Regulatory
Proprietary or Trade Name:	NormaTec PCD-T and NormaTec PCD-B
Common/Usual Name:	Compressible limb sleeve
Classification Name/Code:	JOW - Compressible limb sleeve.Class II
Device Name:	NormaTec PCD-T and NormaTec PCD-B
Predicate Devices:	K013436 – NormaTec PCD

Device Description:

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Intended User

Lay users and professional

Patient Population

Adults

Indications for Use:

The NormaTec PCD-T and PCD-B are intended to apply pressure to the extremities to treat:

Lymphedema and other edematous conditions, including

Congenital lymphedema (Millroy's disease, lymphedema praecox,
and lymphedema tarda)
Post-mastectomy lymphedema ●
Post-infection lymphedema
. Post-traumatic lymphedema
. Post-surgical lymphedema
. Post-radiation-treatment lymphedema
Venous insufficiency
Venous stasis ulceration ●

and to prevent:

Deep Vein Thrombosis

Environment of Use:

Home, hospital or other health care setting

Contraindications:

Contraindicated for patients with acute Deep Vein Thrombosis. This contraindication is identical to the predicate.

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Differences Between the PCD-T and PCD-B

The table below details features available on PCD-T that are not available on PCD-B

Characteristic	PCD-B	PCD-T
Power on: The system recalls and displays the last used settings for:	X	X
Treatment time	X	X
Treatment mode
Therapy mode		X
Rehab mode - recalls zone focus
Custom - recalls all settings
Recovery Flush
Appliance type		X
Power level	X	X
Number of zones	X	X
Rest time	X	X
Brightness settings		X
Time
Add time
Before treatment	X	X
During treatment
Decrease time	X	X
Before treatment
During treatment
Continuous mode	X	X
Counter
Count down - 1 second increments	X	X
Count up (continuous mode) – 1 second increments
Compliance - Trip meter – reset by User		X
Chronometer Odometer – cannot be reset by User		X
Pressure
Increase level
Before treatment	X	X
During treatment
Decrease level
Before treatment
During treatment	X	X
Treatment mode – Can only be changed before treatment begins
NormaTec Pulse	X	X
Sequential	X	X
Rest Time
View or change rest time – before treatment	X	X
# of zones
Change number of zones – before treatment	X	X
Treatment
Starting	X	X
Pause	X	X
Un-pause	X	X
End – If timer reaches 0:00°, treatment will continue until Rest period isreached. The user is given options to either:	X	X
Add time
Continue until cycle is finished
Quit

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510(k) Summary
Battery charging
Displays battery level	X	X
Displays when battery is charging	X	X
Power off
No treatment in process	X	X
Treatment in process	X	X
Appliance type
Select appliance type - boot, arm, hipNote: If hip appliance is selected, treatment mode defaults to 2-zonetreatment		X
Therapy mode
Recovery flush
Preset Pulse time / Pulse pressure values		X
Appliance type applicable - Boot, arm, hip
Rehab
Preset Pulse time / Pulse pressure values		X
Leg appliance - Foot/ankle, calf, knee, lower quad, upper quad
Arm appliance - hand/wrist, forearm, elbow, bicep, shoulder
Hip appliance – Quadriceps, hip
Custom Settings		X
Allows user to program NormaTec Pulse pressure and timevalues for each zone
Pressure range - 30-100 mmHg, user can select in 10mmHgincrements
Time range - 15 seconds to 4 minutes, user can select in 15second increments
Display settings adjustmentBrightness controls		X

Predicate Device Comparison:

The PCD-T and PCD-B were compared to the predicate NormaTec PCD - K013436 in the device comparison table below, also includes is a table that shows equivalence to a reference device NormaTec Pulse and Pulse Pro for the hip appliance.

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NormaTec PCD-T and PCD-B

510(k) Summary

Model Name510(k) Number	New DeviceNormaTec PCD-T and PCD-B510(k) TBD	Predicate DeviceNormaTec PCD510(k) K013436	Comment
Manufacturer	NormaTec Industries	NormaTec Industries
Indications for use	The NormaTec PCD-T and PCD-B are intended toapply pressure to the extremities to treat:Lymphedema and other edematous conditions,includingCongenital lymphedema (Millroy'sdisease, lymphedema praecox,and lymphedema tarda)Post-mastectomy lymphedemaPost-infection lymphedemaPost-traumatic lymphedemaPost-surgical lymphedemaPost-radiation-treatment lymphedemaVenous insufficiencyVenous stasis ulcerationand to prevent:Deep Vein Thrombosis	The NormaTec PCD is intended to apply pressureto the extremities to treat:Lymphedema and other edematous conditions,includingCongenital lymphedema (Millroy'sdisease, lymphedema praecox,and lymphedema tarda)Post-mastectomy lymphedemaPost-infection lymphedemaPost-traumatic lymphedemaPost-surgical lymphedemaPost-radiation-treatment lymphedemaVenous insufficiencyVenous stasis ulcerationand to prevent:Deep Vein Thrombosis	Identical
Contraindications	Contraindicated for patients with acute Deep VeinThrombosis.	Contraindicated for patients with acute Deep VeinThrombosis.	Identical
Prescriptive	Rx	Rx	Identical
Power Source(s)	12 DC via an IEC 60601-1 compliant power supply(100-240 VAC input)Optional Integrated rechargeable battery	12 DC via an IEC 60601-1 compliant power supply(100-240 VAC input)	PCD-T and PCD-Bhave an optionalintegral battery notrequired forfunction.
Software/Firmware/Microprocessor Control	Microprocessor	Microprocessor	Same controltechnology
Technology	Compressor and valve system which sequentiallyinflates cells of appliance	Compressor and valve system which sequentiallyinflates cells of appliance	Identical technology
Compliance with Voluntarystandards	ES 60601-1, IEC 60601-1-2, IEC 60601-1-11	IEC 60601-1, IEC 60601-1-2	PCD-T and PCD-Bcomply withcurrently recognizedversion of 60601-1
			and home usestandard
Device	30 - 110 mmHg	30 - 110 mmHg	Identical
Pressure range
Treatment Time	Stays on until the user turns itoff or can be set up to turn off in a range of 10 to175 minutes	Stays on until the user turns itoff	Added ability totime treatment
Inflation/deflation cycle type	Sequential Gradient, Peristaltic and Pulsing	Sequential Gradient, Peristaltic and Pulsing	Identical
Appliance contact surfacematerial	200 denier nylon with a polyurethanelaminate/extrusion	200 denier nylon with a polyurethanelaminate/extrusion	Identical
Number of Inflatable appliancesegments	5 or less	5 or less	Identical
Weight	3.6 pounds (incl. battery)	14 pounds	Similar
Dimensions (W x H x D)	4" x 5" x 9"	14.2" x 8.6" x 12.3"	Similar
Housing Materials andConstructions	Molded ABS enclosure (94V0)	Thermoplastic	Similar
Patient contact	Non-conductive appliances	Non-conductive appliances	Identical

Page 5.5

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NormaTec PCD-T and PCD-B

510(k) Summary

Model Name510(k) Number	New DeviceNormaTec PCD-T and PCD-B510(k) TBD	Predicate DeviceNormaTec PCD 510(k) K013436	Reference DeviceNormaTec Pulse andPulse Pro 510(k) K160608	Comment
Appliances	Leg, Arm, Hip	Leg, Arm	Leg, Arm, Hip	Leg and arm appliances aresame design and constructionas those cleared in 510(k)K013436.The leg , arm and hipappliances are identical tothose cleared in 510(k)K160608

Page 5.6

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Performance Testing

Bench:

The device has been tested to ensure that it all requirements have been met, this includes:

Testing of all controls ●
. Testing of all indicators
Testing of battery state indicators
Testing of performance
Testing of hazard mitigations

The device has also been tested to the requirements of the following standards:

AAMI / ANSI ES60601-1:2005 Medical electrical equipment part 1: general ● requirements for basic safety and essential performance
. IEC 60601-1-2: 2007 -Collateral standard: Electromagnetic Compatibility -Requirements and Tests

● IEC 60601-1-11: 2010, Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

Animal:

No animal testing was performed

Clinical:

No clinical testing was performed

Conclusion

The NormaTec PCD-T and PCD-B are substantially equivalent to the predicates in: indications for use, contraindications, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise questions of safety and effectiveness.

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).

Indications for Use

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Device Description:

Intended User

Patient Population

Indications for Use:

Environment of Use:

Contraindications:

Differences Between the PCD-T and PCD-B

Predicate Device Comparison:

NormaTec PCD-T and PCD-B

510(k) Summary

NormaTec PCD-T and PCD-B

510(k) Summary

Performance Testing

Bench:

Animal:

Clinical:

Conclusion

§ 870.5800 Compressible limb sleeve.

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