Who is the manufacturer of PlasmaWave?

Manamed, Inc. filed the 510(k) submission for PlasmaWave (K211253).

What is the FDA product code for PlasmaWave?

JOW. It is classified under 21 CFR 870.5800 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for PlasmaWave?

510(k) clearance (submission type: Special).

What are the predicate devices for PlasmaWave?

PlasmaFlow (K160318); Cirona 6200 Deep Vein Thrombosis Prevention System (K141578).

Who can help prepare an FDA 510(k) submission like PlasmaWave?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PlasmaWave

K211253 · Manamed, Inc. · JOW · May 26, 2021 · Cardiovascular

Device Facts

Record ID	K211253
Device Name	PlasmaWave
Applicant	Manamed, Inc.
Product Code	JOW · Cardiovascular
Decision Date	May 26, 2021
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.5800
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The PlasmaWave is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: - Aid in the prevention of DVT; - Enhance blood circulation; - Diminish post-operative pain and swelling; - Reduce wound healing time; - Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time.

Device Story

PlasmaWave is a portable, battery-powered, prescription-only pneumatic compression system for home or clinical use. Device consists of an electronically controlled air pump/solenoid valve unit housed in a plastic case, connected via tubing to a single-use inflatable limb wrap. User interface includes Power, Mode, and Leg buttons, LCD display, and LED indicators (Working, Charging, Warming). Device operates by delivering cyclic, intermittent pneumatic pressure to lower extremities to stimulate muscle contractions and blood flow. Cycle time is approximately 60 seconds (inflation followed by deflation/rest). Healthcare providers prescribe the device to prevent DVT, manage edema, and aid wound healing. System includes audible/visual alarms for low pressure and low battery. Benefits include improved circulation and reduced risk of DVT in patients with limited mobility.

Clinical Evidence

Bench testing only. Device validated for electrical safety (ANSI AAMI ES60601-1) and electromagnetic compatibility (IEC 60601-1-2). Performance verified through bench testing of physical, electrical, and functional requirements. Software verified per FDA guidance.

Technological Characteristics

Portable, battery-powered (3.7V) pneumatic compression system. Features microprocessor-controlled micro-pump and solenoid valve. Single-chamber inflatable wrap made of non-latex, non-woven medical fabric. Dimensions: 220x70x48.5 mm. Weight: 0.38 kg. Connectivity: AC adapter/charger port. Operating mode: Continuous. Cycle time: ~60s. Pressure: 55 mmHg. Software: Moderate level of concern.

Indications for Use

Indicated for patients requiring venous return stimulation to prevent DVT, enhance circulation, reduce post-op pain/swelling, accelerate wound healing, or treat stasis dermatitis, venous/arterial/diabetic ulcers, chronic venous insufficiency, and lower limb edema. Also for DVT prophylaxis in stationary individuals. Contraindicated for patients with suspected/active/untreated DVT, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, active infection, or where increased venous/lymphatic return is undesirable. Not for use on legs with vein ligation, gangrene, dermatitis, open wounds, recent skin grafts, massive edema, extreme deformity, neuropathy, or insensitive skin.

Regulatory Classification

Identification

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

Predicate Devices

PlasmaFlow (K160318)
Cirona 6200 Deep Vein Thrombosis Prevention System (K141578)

Related Devices

K160318 — PlasmaFlow · Manamed, Inc. · Apr 1, 2016
K200285 — VenaOne · Vena Group, LLC · Jul 2, 2020
K193020 — VenaPro Vascular Therapy System · Innovamed Health, LLC · Dec 4, 2019
K191107 — Plexus · Alleva Medical (D.G), Ltd. · Aug 27, 2019
K133274 — VENA PRO · Innovamed Health, LLC · Feb 12, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 26, 2021 ManaMed, Inc. % Bill Quanqin Dai, Ph.D. JKH USA, LLC 14271 Jeffrev Rd. #246 Irvine, California 92620 Re: K211253 Trade/Device Name: PlasmaWave Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 14, 2021 Received: April 26, 2021 ## Dear Dr. Dai: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Nicole Gillette Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K211253 Device Name PlasmaWave Indications for Use (Describe) The PlasmaWave is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients blood flow in the extremities (stimulating muscle contractions). This device can be used to: - · Aid in the prevention of DVT; - · Enhance blood circulation: - · Diminish post-operative pain and swelling; - · Reduce wound healing time; · Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------------------------------------| | | <div> <input type="checkbox"/> </div> | | | <div> <input type="checkbox"/> </div> | 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}------------------------------------------------ #### 510(k) Summary ## 1. Submitter's Information Submitter: ManaMed. Inc. Address: 5240 W. Charleston Blvd. Las Vegas, NV 89146 Date of Preparation: 04/16/2021 ## 2. Subject Device Trade/Device Name: PlasmaWave Regulation Description: Compressible Limb Sleeve Regulation Medical Specialty: Cardiovascular Review Panel: Cardiovascular Product Code: JOW Regulation Number: 21 CFR 870.5800 Device Class: II Use: Prescription #### 3. Predicate device Primary Predicate Device: PlasmaFlow 510(k) Number: K160318 Clearance Date: April 1, 2016 Submitter: ManaMed, Inc. Predicate Device: Cirona 6200 Deep Vein Thrombosis Prevention System 510(k) Number: K141578 Clearance Date: June 27, 2014 Submitter: Devon Medical, Inc. #### 4. Description of Subject Device The PlasmaWave is a lightweight, portable, rechargeable battery powered prescriptive device. It is intended to be used in the home or clinical setting by or under the direction of a medical professional to help stimulate blood flow as an aid in the prevention of deep vein thrombosis (DVT). The PlasmaWave utilizes pneumatically controlled, single-chamber wraps actuated by an electronically controlled unit of the air pump and solenoid valve via the tubing. All pump, battery and control components are protectively housed in a plastic case that is connected to a single use inflatable wrap via tubing. A Power On/Off button, a Mode (M) button, a Leg button, three LED indicators (Working, Charging, and Warming), and a LCD display provide user interface. There are also two tubing ports for connecting the tubing and a charging port for connecting the battery charger/AC adapter at the bottom of the control unit. ## 5. Indications for Use Prescription Use: The PlasmaWave is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: {4}------------------------------------------------ - Aid in the prevention of DVT; • - Enhance blood circulation; - Diminish post-operative pain and swelling; - Reduce wound healing time; - Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time. #### 6. Summary of Substantial Equivalence The following comparison Table 1 summarizes the comparison between the subject device and the predicate device, indicating the intended use and technical characteristics of the subject device are substantially equivalent to those of the predicate device. | | Subject Device | Primary Predicate Device | Predicate Device | Equivalence | |--------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | N/A | K160318 | K141578 | N/A | | Submitter | ManaMed, Inc. | ManaMed, Inc. | Devon Medical, Inc. | N/A | | Device Name/Model | PlasmaWave | PlasmaFlow | Cirona 6200 Deep Vein Thrombosis Prevention System | N/A | | Intended Use | The PlasmaWave is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (stimulating muscle contractions). This device can be used to: Aid in the prevention of DVT; Enhance blood circulation; Diminish post- operative pain and swelling; Reduce wound healing time; Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time. | The PlasmaFlow, model PF0001, is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to: Aid in the prevention of DVT: Enhance blood circulation; Diminish post- operative pain and swelling: Reduce wound healing time; Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. The unit can also be used as an aid in the prophylaxis for DVT by persons expecting to be stationary for long periods of time. | The Cirona 6200 Series system is a prescription device intended to be used preventatively to increase venous blood flow in patients at risk of deep vein thrombosis due to the associated risk factors for thrombus formation during: trauma, critical care, general medicine, general surgery, as well as neurological, orthopedic, urologic, obstetric conditions and treatments. | Identical | | Prescription or OTC | Prescription | Prescription | Prescription | Identical | | Power Source(s) | Rechargeable battery | Rechargeable battery | Rechargeable battery | Identical | | Battery Specifications | 3.7V rechargeable battery | 3.7V rechargeable battery | 10.8V rechargeable battery | Identical or similar. The voltage difference of batteries will not raise any new issue of the safety or effectiveness. | | Battery Charge | Takes approximately 4 hours (from depleted state). | Takes approximately 4 hours (from depleted state). | Takes approximately 5 hours (from depleted state). | Identical or similar. The difference of charging time does not change the product performance or parameters, which will not raise any new issue of the safety or effectiveness. | | Power Supply | Input: 100 - 240 Vac, 50 - 60 Hz, Output: 12 Vdc @ 2 A | Input: 100 - 240 Vac, 50 - 60 Hz, Output: 5 Vdc @ 1 A | Input: 100 - 240 Vac, 50 - 60 Hz, Output: 14 Vdc @ 2 A | Similar. The voltage difference of power supply used does not change the product performance or parameters, which will not raise any new issue of the safety or effectiveness. | | Internal rechargeable batteries | Yes | Yes | Yes | Identical | | Compliance with Voluntary Standards? | Yes | Yes | Yes | Identical | | Electrical Safety Mechanical Safety Chemical Safety Thermal Safety Radiation Safety? | Yes | Yes | Yes | Identical | | Functions and design | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower extremities. | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower extremities. | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower extremities | Identical | | Contraindication(s) | The PlasmaFlow MUST NOT be used to treat the following conditions: Persons with suspected, active or untreated: deep vein thrombosis, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, or an active infection. On the legs where cuffs would interfere with the following conditions: vein ligation, gangrene, dermatitis, open wounds, a recent skin graft, massive edema or extreme deformity of the leg. On any neuropathy. On extremities that are insensitive to pain. Where increased venous or lymphatic return is undesirable. | The PlasmaFlow MUST NOT be used to treat the following conditions: Persons with suspected, active or untreated: deep vein thrombosis, ischemic vascular disease, severe arteriosclerosis, pulmonary edema, severe congestive heart failure, thrombophlebitis, or an active infection. On the legs where cuffs would interfere with the following conditions: vein ligation, gangrene, dermatitis, open wounds, a recent skin graft, massive edema or extreme deformity of the leg. On any neuropathy. On extremities that are insensitive to pain. Where increased venous or lymphatic return is undesirable. | The Cirona 6200 Series system should NOT be used in the following conditions: · Severe atherosclerosis or other ischemic vascular diseases • Suspected or known acute deep vein thrombosis • Severe congestive cardiac failure • Existing pulmonary edema • Existing pulmonary embolisms • Extreme deformity of the limbs • Any local skin or tissue condition in which the garments would interfere: · Gangrene • Untreated or infected wounds · Recent skin graft · Dermatitis • Known presence of malignancy in the legs | Identical | | | | | • Limb infections, including cellulitis, that have not received antibiotic coverage • Presence of lymphangiosarcoma | | | Target Population / Intended Users | Patients who need venous return. | Patients who need venous return. | Patients who need venous return. | Identical | | Where Used | Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility | Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility | Home, Hospital, Surgery Center, Altitude travel, areas of limited mobility | Identical | | Application | Non-invasive / external | Non-invasive / external | Non-invasive / external | Identical | | Portability | Portable, ambulant | Portable, ambulant | Portable, ambulant | Identical | | Basis of operation | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower extremities. | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower extremities. | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower extremities. | Identical | | Anatomical Site / Location of treatment application | Lower extremities | Lower extremities | Lower extremities | Identical | | System management | Electronic, microprocessor controlled | Electronic, microprocessor controlled | Electronic, microprocessor controlled | Identical | | Pressure Source | Micro pump controlled by electronic processor | Micro pump controlled by electronic processor | Micro pump controlled by electronic processor | Identical | | Operating Mode | Continuous Operation | Continuous Operation | Continuous Operation | Identical | | Working Pressure | Preset at 55 mmHg | Preset at 55 mmHg | Preset at 40 mmHg | Identical or similar. The working pressure of the subject device is identical to that of the<b…