INTERMITTENT PNEUMATIC COMPRESSION DEVICE

K141390 · Wuhan Landing Medical Hi-Tech, Ltd. · JOW · Nov 18, 2014 · Cardiovascular

Device Facts

• Record ID: K141390
• Device Name: INTERMITTENT PNEUMATIC COMPRESSION DEVICE
• Applicant: Wuhan Landing Medical Hi-Tech, Ltd.
• Product Code: JOW · Cardiovascular
• Decision Date: Nov 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LD Q-IPC III is a system to prevent DVT(Deep Vein Thrombosis) by improving the blood velocity of patients. Leg Compression The use of the product with Calf Cuff and Thigh Cuff is indicated for: 1. Deep vein thrombosis and pulmonary embolism prophylaxis. Foot Compression The use of the product with Foot Cuff is indicated for: 1. Circulation enhancement. 2. Deep vein thrombosis prophylaxis. 3. Edema-Acute. 4. Edema-Chronic. 5. Extremity pain incident to trauma or surgery. 6. Leg Ulcers. 7. Venous stasis /Venous insufficiency.

Device Story

LD Q-IPC III is an intermittent pneumatic compression system; prevents DVT by increasing blood velocity. System comprises controller, tubing, and single-patient-use cuffs (calf, thigh, foot). Controller delivers air to cuffs; sequentially pressurizes from distal to proximal chambers; provides interval for vein refilling. Used in clinical settings; operated by healthcare providers. Output is mechanical compression of limbs; affects venous return and blood flow; benefits patients by reducing DVT incidence. Controller features audible/visual alarms for pressure/system errors.

Clinical Evidence

Bench testing only. Device performance verified through compliance with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ISO 10993 (biocompatibility: cytotoxicity, irritation, sensitization). Software verification conducted per FDA guidance.

Technological Characteristics

Microprocessor-controlled pneumatic compression system. Components: controller, tubing, cuffs. Power: AC 100-240V, 50-60Hz. Compression: Sequential/gradient (thigh/calf), uniform (foot). Pressure range: 30-60 mmHg (thigh/calf), 120-140 mmHg (foot). Connectivity: Standalone. Standards: IEC 60601-1, ISO 10993-1/5/10.

Indications for Use

Indicated for patients requiring DVT and pulmonary embolism prophylaxis, circulation enhancement, edema management (acute/chronic), extremity pain relief (trauma/surgery), leg ulcer treatment, and venous stasis/insufficiency management.

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

• Veinoflow SCD, LBTK-M-I 5001 (K123830)

Submission Summary (Full Text)

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Public Health Service

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

November 18, 2014

Wuhan Landing Medical Hi-Tech Co., Ltd Yan Liu Quality Manager 818 Gaoxin Rd East Lake High Tech Development Zone Floors 1 & 2, Units B & C & D, Building No. B7 Med Equipment Park Wuham, CH 430206

Re: K141390

> Trade/Device Name: Intermittent pneumatic compression device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: Undated Received: September 15, 2014

Dear Yan Liu,

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

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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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 [phone] or [phone] 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" (21 CFR 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

M.A. Hilleman

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K141390

Device Name

Intermittent pneumatic compression device

#### Indications for Use (Describe)

The LD Q-IPC III is a system to prevent DVT(Deep Vein Thrombosis) by improving the blood velocity of patients.

Leg Compression

- The use of the product with Calf Cuff and Thigh Cuff is indicated for:
1. Deep vein thrombosis and pulmonary embolism prophylaxis.

Foot Compression

The use of the product with Foot Cuff is indicated for:

- 1. Circulation enhancement.
- 2. Deep vein thrombosis prophylaxis.
- 3. Edema-Acute.
- 4. Edema-Chronic.
- 5. Extremity pain incident to trauma or surgery.
- 6. Leg Ulcers.
- 7. Venous stasis /Venous insufficiency.

## 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)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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## Section 5 - 510(k) Summary

Date of Summary Preparation: 9/9/2014

#### 1. Submitter's Identifications

Submitter's Name: Wuhan Landing Medical Hi-Tech Co., LTD Address: Floors 1&2,Units B&C&D,Building No.B7 Medical Equipment Park,818 Gaoxin Road East Lake High Tech Development Zone 430206 Wuhan, Hubei,China Contact Person: Yan Liu Contact Email Address: [e-mail] Telephone: [phone] Fax: [phone]

#### 2. Correspondent's Identifications

Correspondent's Name: Wuhan Landing Medical Hi-Tech Co.,LTD Address: Floors 1&2,Units B&C&D,Building No.B7 Medical Equipment Park,818 Gaoxin Road East Lake High Tech Development Zone 430206 Wuhan, Hubei,China Contact Person: Yan Liu Contact Email Address: [e-mail] Telephone: [phone] Fax: [phone]

#### 3. Name of the Device

Device Classification Name: sleeve, limb, compressible Product Name: Compressible limb sleeve Trade Name: Intermittent pneumatic compression device Model: LD Q-IPC III Classification Panel: Cardiovascular Product Code: JOW Device Classification: Class II

#### 4. The Predicate Devices

Veinoflow SCD, LBTK-M-I 5001 K123830

#### 5. Device Description

The LD Q-IPC III Intermittent pneumatic compression device is a pneumatic compression device that noninvasively helps reduce the incidence of deep vein thrombosis, a potentially life threatening condition.

The LD Q-IPC III Intermittent pneumatic compression device consists of the controller, the Tubing Sets and single-patient used cuff. The cuff includes calf cuffs, thigh cuffs and foot cuffs.

The controller will deliver air to the cuffs and sequentially pressurize them. Cuffs will be

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# Wuhan Landing Medical Hi-Tech Co,LTD

pressurized from the distal air chamber to the proximal air chamber. After the compression, the controller will allow an interval time for vein refilling, before the controller starts to pressurize the cuffs again. The cycles will be repeated throughout the time the unit is in use or for the duration of the default operating time.

#### 6. Intended Use of Device

The LD Q-IPC III is a system to prevent DVT(Deep Vein Thrombosis) by improving the blood velocity of patients.

Leg Compression

The use of the product with Calf Cuff and Thigh Cuff is indicated for:

- 1. Deep vein thrombosis and pulmonary embolism prophylaxis.
#### Foot Compression

The use of the product with Foot Cuff is indicated for:

- 1. Circulation enhancement.
- 2. Deep vein thrombosis prophylaxis.
- 3. Edema-Acute.
- 4. Edema-Chronic.
- 5. Extremity pain incident to trauma or surgery.
- 6. Leg Ulcers.
- 7. Venous stasis /Venous insufficiency.

#### 7. Summary of Substantial Equivalence

Table : The difference between LD Q-IPC III and Predicate Veinoflow SCD (K123830)

| | New Device | Predicate Device |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K 141390 | K123830 |
| Product Code: | JOW | JOW |
| Proprietary Name: | Intermittent Pneumatic Compression Device | Veinoflow SCD, LBTK-M-I 5001 |
| Manufacturer: | Wuhan Landing Medical Hi-Tech Co., Ltd | Dalian Labtek Science & Development Co., Ltd |
| Indication for use: | The LD Q-IPC III is a system to prevent | Veinoflow SCD system, Model LBTK-M-I 5001 |
| | DVT(Deep Vein Thrombosis) by improving | is a system to prevent DVT (Deep Vein |
| | the blood velocity of patients. LD Q-IPC III | Thrombosis) by improving the blood velocity of |
| | is indicated for Circulation enhancement, | patients. LBTK-M-I 5001 is indicated for |
| | Deep vein thrombosis and pulmonary | Circulation enhancement, Deep vein thrombosis |
| | embolism prophylaxis, Edema-Acute, | and pulmonary embolism prophylaxis, |
| | Edema-Chronic, Extremity pain incident to | Edema-Acute, Edema-Chronic, Extremity pain |
| | trauma or surgery, Leg Ulcers, Venous | incident to trauma or surgery, Leg Ulcers, Venous |
| | stasis /Venous insufficiency | stasis /Venous insufficiency |
| Components | Pump controller, thigh cuffs, calf cuffs, foot<br>cuffs, air supply tubes, power line | Pump controller, thigh cuffs, calf cuffs, foot cuffs,<br>battery, air supply tubes, power line |
| Ingress of Water | Ordinary | Ordinary |
| protection | | |
| Compression type | thigh cuffs & calf cuffs: Sequential, Gradient<br>foot cuffs: Uniform | thigh cuffs & calf cuffs: Sequential, Gradient<br>foot cuffs: Uniform |
| Compression time | Single thigh cuffs: 6s Compression<br>Dual thigh cuffs: 12s Compression<br>Single calf cuffs: 4s Compression<br>Dual calf cuffs: 8s Compression<br>Single foot cuffs: 2.5s Compression<br>Dual foot cuffs: 5s Compression | Single thigh cuffs: 5.5s Compression<br>Dual thigh cuffs: 11s Compression<br>Single calf cuffs: 4s Compression<br>Dual calf cuffs: 8s Compression<br>Single foot cuffs: 2.5s Compression<br>Dual foot cuffs: 5s Compression |
| Deflation time | 2-3s | 2-3s |
| Default inflatable<br>Interval time | 48s | 48s |
| Adjustable<br>inflatable interval<br>time | 24s, 48s, 60s | 24s, 48s, 60s |
| Default Pressure | thigh cuffs & calf cuffs: 45 mmHg<br>foot cuffs: 130 mmHg | thigh cuffs & calf cuffs: 40 mmHg<br>foot cuffs: 130 mmHg |
| Adjustable<br>Pressure | thigh cuffs & calf cuffs: 30-60 mmHg<br>foot cuffs: 120-140 mmHg | thigh cuffs & calf cuffs: 30-60 mmHg<br>foot cuffs: 120-140 mmHg |
| Mode of operation | Continuous | Continuous |
| Application mode | Single thigh cuffs Compression<br>Dual thigh cuffs Compression<br>Single calf cuffs Compression<br>Dual calf cuffs Compression<br>Single foot cuffs Compression<br>Dual foot cuffs Compression | Single thigh cuffs Compression<br>Dual thigh cuffs Compression<br>Single calf cuffs Compression<br>Dual calf cuffs Compression<br>Single foot cuffs Compression<br>Dual foot cuffs Compression<br>Simultanous single thigh cuffs and single calf<br>cuffs Compression |
| Bed Hook | Yes | Yes |
| Power cord<br>storage | Yes | Yes |
| Audible/Visual<br>Alarms | Low Pressure, High Pressure, Pump Error,<br>Valve Error, System Error, | No garment, Pump Error, Valve Error,<br>Temperature Error, Software Error, System Error,<br>High Pressure, Low Pressure, Low Battery |
| Controll<br>Dimensions | Length: 280mm; Width: 145mm; Height:<br>250mm | Length: 240mm; Width: 140mm; Height: 263mm |
| Controll Weight | 3kg | 3.5kg |
| Power<br>Requirement | AC 100-240V, 60 VA, 50-60Hz | AC 100-240V, 50 VA, 50-60Hz |
| Battery | No | Yes |
| Shipping Unit | Each | Each |
| Standard | IEC60601-1 | IEC60601-1 |
| | ISO10993-1 | ISO10993-1 |
| | ISO10993-5 | ISO10993-5 |
| | ISO10993-10 | ISO10993-10 |
| Non-sterile | Non-sterile | Non-sterile |
| Microprocessor<br>Control | Yes | Yes |

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# Wuhan Landing Medical Hi-Tech Co,LTD

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# Wuhan Landing Medical Hi-Tech Co,LTD

### 8. Substantial Equivalence:

The proposed devices of LD Q-IPC III have the same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device. The differences only exist in battery, default pressure, and audible/visual alarms. These differences are slight and do not influence the effectiveness and safety of the device.

### 9. Non-Clinical Tests Performed:

The following testing was performed on the LD Q-IPC III in accordance with the requirements of the design control regulations and established quality assurance procedures.

IEC60601-1:2005+CORR.1(2006)+CORR.2(2007),Medical electrical equipment-Part 1:General requirements for basic safety, and essential performance.

IEC60601-1-2:2007, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and tests.

ISO10993-1: 2009, Biological evaluation of medical devices-Part 1:Evaluation and testing within a risk management process

ISO10993-5:2009, Biological evaluation of medical devices-Part 5: Tests for In Vitro cytotoxicity. ISO10993-10:2010, Biological evaluation of medical devices-Part10: Tests for irritation and skin sensitization

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

#### 10. Conclusion:

The proposed device LD Q-IPC III are determined to be Substantially Equivalent (SE) to the predicate device, Veinoflow SCD, LBTK-M-I 5001 in respect of safety and effectiveness.

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