NormaTec PCD-T and PCD-B

{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) 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) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. " {3}------------------------------------------------ | Official Address: | NormaTec Industries, LP<br>44 Glen Ave<br>Newton, MA 02459<br>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.<br>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<br>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<br>Note: If hip appliance is selected, treatment mode defaults to 2-zone<br>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<br>values for each zone | | | | Pressure range - 30-100 mmHg, user can select in 10mmHg<br>increments | | | | Time range - 15 seconds to 4 minutes, user can select in 15<br>second increments | | | | Display settings adjustment<br>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<br>510(k) Number | New Device<br>NormaTec PCD-T and PCD-B<br>510(k) TBD | Predicate Device<br>NormaTec PCD<br>510(k) K013436 | Comment | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Manufacturer | NormaTec Industries | NormaTec Industries | | | Indications for use | The NormaTec PCD-T and PCD-B are intended to<br>apply pressure to the extremities to treat:<br>Lymphedema and other edematous conditions,<br>including<br>Congenital lymphedema (Millroy's<br>disease, lymphedema praecox,<br>and lymphedema tarda)Post-mastectomy lymphedemaPost-infection lymphedemaPost-traumatic lymphedemaPost-surgical lymphedemaPost-radiation-treatment lymphedemaVenous insufficiencyVenous stasis ulcerationand to prevent:<br>Deep Vein Thrombosis | The NormaTec PCD is intended to apply pressure<br>to the extremities to treat:<br>Lymphedema and other edematous conditions,<br>including<br>Congenital lymphedema (Millroy's<br>disease, lymphedema praecox,<br>and lymphedema tarda)Post-mastectomy lymphedemaPost-infection lymphedemaPost-traumatic lymphedemaPost-surgical lymphedemaPost-radiation-treatment lymphedemaVenous insufficiencyVenous stasis ulcerationand to prevent:<br>Deep Vein Thrombosis | Identical | | Contraindications | Contraindicated for patients with acute Deep Vein<br>Thrombosis. | Contraindicated for patients with acute Deep Vein<br>Thrombosis. | Identical | | Prescriptive | Rx | Rx | Identical | | Power Source(s) | 12 DC via an IEC 60601-1 compliant power supply<br>(100-240 VAC input)<br>Optional Integrated rechargeable battery | 12 DC via an IEC 60601-1 compliant power supply<br>(100-240 VAC input) | PCD-T and PCD-B<br>have an optional<br>integral battery not<br>required for<br>function. | | Software/Firmware/Microproces<br>sor Control | Microprocessor | Microprocessor | Same control<br>technology | | Technology | Compressor and valve system which sequentially<br>inflates cells of appliance | Compressor and valve system which sequentially<br>inflates cells of appliance | Identical technology | | Compliance with Voluntary<br>standards | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 | IEC 60601-1, IEC 60601-1-2 | PCD-T and PCD-B<br>comply with<br>currently recognized<br>version of 60601-1 | | | | | and home use<br>standard | | Device | 30 - 110 mmHg | 30 - 110 mmHg | Identical | | Pressure range | | | | | Treatment Time | Stays on until the user turns it<br>off or can be set up to turn off in a range of 10 to<br>175 minutes | Stays on until the user turns it<br>off | Added ability to<br>time treatment | | Inflation/deflation cycle type | Sequential Gradient, Peristaltic and Pulsing | Sequential Gradient, Peristaltic and Pulsing | Identical | | Appliance contact surface<br>material | 200 denier nylon with a polyurethane<br>laminate/extrusion | 200 denier nylon with a polyurethane<br>laminate/extrusion | Identical | | Number of Inflatable appliance<br>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<br>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<br>510(k) Number | New Device<br>NormaTec PCD-T and PCD-B<br>510(k) TBD | Predicate Device<br>NormaTec PCD 510(k) K013436 | Reference Device<br>NormaTec Pulse and<br>Pulse Pro 510(k) K160608 | Comment | |-----------------------------|------------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Appliances | Leg, Arm, Hip | Leg, Arm | Leg, Arm, Hip | Leg and arm appliances are<br>same design and construction<br>as those cleared in 510(k)<br>K013436.<br>The leg , arm and hip<br>appliances are identical to<br>those cleared in 510(k)<br>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.