(30 days)
No
The summary describes a device that uses air compression and a control system to simulate manual massage. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as applying "pressure to the extremities to treat" various medical conditions and providing "noninvasive air compression therapy for the treatment of lymphedema, venous insufficiency, other edemas, and venous stasis ulceration and to prevent deep venous thrombosis," all of which are therapeutic indications.
No
The device is described as providing noninvasive air compression therapy for treatment and prevention of various conditions, not for diagnosing them.
No
The device description explicitly details hardware components such as an air compressor unit, inflatable "appliances" (cuffs), plastic air tubing, and an AC-DC adaptor. It is a physical compression therapy device controlled by a system, not solely software.
Based on the provided information, the NormaTec PCD-T and NormaTec PCD-B devices are not In Vitro Diagnostic (IVD) devices.
Here's why:
- Intended Use: The intended use is to apply pressure to the extremities to treat and prevent various conditions like lymphedema, venous insufficiency, and deep vein thrombosis. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as providing noninvasive air compression therapy. It physically interacts with the body to provide treatment.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples (blood, urine, tissue, etc.) or providing information for the diagnosis of a disease or condition.
- No Mention of IVD Characteristics: The description does not include any elements typically associated with IVD devices, such as reagents, assays, or analysis of biological markers.
In summary, the NormaTec PCD-T and PCD-B are therapeutic devices that provide physical compression, not diagnostic devices that analyze biological samples.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities
Indicated Patient Age Range
Adults
Intended User / Care Setting
Lay users and professional
Home, hospital or other health care setting
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)
Bench testing was performed:
- 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
No animal testing was performed.
No clinical testing was performed.
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.
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.
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
§ 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).
0
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
1
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
2
Indications for Use
510(k) Number (if known)
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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3
| Official Address: | NormaTec Industries, LP
44 Glen Ave
Newton, MA 02459
Tel - 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:
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)
4
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.
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.
5
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 is | ||
| reached. The user is given options to either: | X | X |
| Add time | ||
| Continue until cycle is finished | ||
| Quit |
6
| 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, hip | ||
| Note: If hip appliance is selected, treatment mode defaults to 2-zone | ||
| treatment | 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 time | ||
| values for each zone | ||
| Pressure range - 30-100 mmHg, user can select in 10mmHg | ||
| increments | ||
| Time range - 15 seconds to 4 minutes, user can select in 15 | ||
| second increments | ||
| Display settings adjustment | ||
| Brightness 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.
7
NormaTec PCD-T and PCD-B
510(k) Summary
| Model Name
510(k) Number | New Device
NormaTec PCD-T and PCD-B
510(k) TBD | Predicate Device
NormaTec PCD
510(k) K013436 | Comment |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Manufacturer | NormaTec Industries | NormaTec Industries | |
| 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 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 pressure
to the extremities to treat:
Lymphedema and other edematous conditions,
including
Congenital lymphedema (Millroy's
disease, 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 Vein
Thrombosis. | Contraindicated for patients with acute Deep Vein
Thrombosis. | 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-B
have an optional
integral battery not
required for
function. |
| Software/Firmware/Microproces
sor Control | Microprocessor | Microprocessor | Same control
technology |
| Technology | Compressor and valve system which sequentially
inflates cells of appliance | Compressor and valve system which sequentially
inflates cells of appliance | Identical technology |
| Compliance with Voluntary
standards | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | IEC 60601-1, IEC 60601-1-2 | PCD-T and PCD-B
comply with
currently recognized
version of 60601-1 |
| | | | and home use
standard |
| Device | 30 - 110 mmHg | 30 - 110 mmHg | Identical |
| Pressure range | | | |
| Treatment Time | Stays on until the user turns it
off or can be set up to turn off in a range of 10 to
175 minutes | Stays on until the user turns it
off | Added ability to
time treatment |
| Inflation/deflation cycle type | Sequential Gradient, Peristaltic and Pulsing | Sequential Gradient, Peristaltic and Pulsing | Identical |
| Appliance contact surface
material | 200 denier nylon with a polyurethane
laminate/extrusion | 200 denier nylon with a polyurethane
laminate/extrusion | Identical |
| Number of Inflatable appliance
segments | 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 and
Constructions | Molded ABS enclosure (94V0) | Thermoplastic | Similar |
| Patient contact | Non-conductive appliances | Non-conductive appliances | Identical |
Page 5.5
8
NormaTec PCD-T and PCD-B
510(k) Summary
| Model Name
510(k) Number | New Device
NormaTec PCD-T and PCD-B
510(k) TBD | Predicate Device
NormaTec PCD 510(k) K013436 | Reference Device
NormaTec Pulse and
Pulse Pro 510(k) K160608 | Comment |
|-----------------------------|------------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Appliances | Leg, Arm, Hip | Leg, Arm | Leg, Arm, Hip | Leg and arm appliances are
same design and construction
as those cleared in 510(k)
K013436.
The leg , arm and hip
appliances are identical to
those cleared in 510(k)
K160608 |
Page 5.6
9
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.