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 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for an intermittent pneumatic compression device (LD Q-IPC III) and primarily focuses on establishing substantial equivalence to a predicate device (Veinoflow SCD, LBTK-M-I 5001).

Based on the information provided in the document, here's an analysis of the acceptance criteria and study details:

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

The document does not explicitly state "acceptance criteria" in terms of specific performance metrics with numerical thresholds (e.g., a certain percentage of DVT reduction). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device. The performance is assessed by comparing the device's technical specifications and intended use against the predicate device.

Table: Acceptance Criteria (Implied by Substantial Equivalence) and Reported Device Performance

Feature/Parameter	Implied Acceptance Criteria (via Predicate Device)	Reported Device Performance (LD Q-IPC III)
Intended Use/Indications	Same as predicate device: DVT prophylaxis, circulation enhancement, edema reduction, extremity pain, leg ulcers, venous stasis/insufficiency.	Same as predicate device: Prevents DVT by improving blood velocity. Indicated for DVT and pulmonary embolism prophylaxis (leg compression), and circulation enhancement, DVT prophylaxis, acute/chronic edema, extremity pain, leg ulcers, venous stasis/insufficiency (foot compression). (Pages 2, 5)
Classification Information	Same as predicate device: Class II, Product Code JOW, Cardiovascular Panel.	Same as predicate device: Class II, Product Code JOW, Cardiovascular Panel. (Page 4)
Design Principle	Same as predicate device (pneumatic compression to improve blood velocity).	Same as predicate device: Pneumatic compression device delivering air to cuffs, sequentially pressurizing them from distal to proximal, followed by an interval for vein refilling. Cycles repeat. (Page 4-5)
Compression Type	Same as predicate device: Sequential, Gradient for thigh/calf, Uniform for foot.	Same as predicate device: Thigh cuffs & calf cuffs: Sequential, Gradient; Foot cuffs: Uniform. (Page 5)
Deflation Time	Same as predicate device: 2-3s.	Same as predicate device: 2-3s. (Page 5)
Default Inflatable Interval	Same as predicate device: 48s.	Same as predicate device: 48s. (Page 5)
Adjustable Inflatable Interval	Same as predicate device: 24s, 48s, 60s.	Same as predicate device: 24s, 48s, 60s. (Page 5)
Adjustable Pressure	Same as predicate device: Thigh/calf: 30-60 mmHg; Foot: 120-140 mmHg.	Same as predicate device: Thigh cuffs & calf cuffs: 30-60 mmHg; Foot cuffs: 120-140 mmHg. (Page 5)
Mode of Operation	Same as predicate device: Continuous.	Same as predicate device: Continuous. (Page 5)
Application Mode	Similar to predicate device (single/dual thigh/calf/foot compression).	Similar to predicate device: Single/Dual thigh cuffs, Single/Dual calf cuffs, Single/Dual foot cuffs Compression. (Predicate also had "Simultaneous single thigh cuffs and single calf cuffs Compression," which the new device does not explicitly list.) (Page 5)
Bed Hook, Power Cord Storage	Present in predicate device.	Present in new device. (Page 5)
Microprocessor Control	Present in predicate device.	Present in new device. (Page 6)
Biocompatibility	Compliance with ISO10993 standards.	Compliance with ISO10993-1, ISO10993-5 (In Vitro cytotoxicity), ISO10993-10 (irritation and skin sensitization). (Page 7)
Electrical Safety	Compliance with IEC60601-1.	Compliance with IEC60601-1:2005+CORR.1(2006)+CORR.2(2007). (Page 7)
Electromagnetic Compatibility (EMC)	Compliance with IEC60601-1-2.	Compliance with IEC60601-1-2:2007. (Page 7)
Software Verification	Following FDA guidance.	Carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. (Page 7)
Differences noted:	Predicate has battery, different default pressure, and more alarms.	New device does not have a battery. Default pressure for thigh/calf is 45 mmHg (predicate: 40 mmHg). New device has fewer types of alarms. (The document states these differences are "slight and do not influence the effectiveness and safety of the device.") (Pages 5, 7)

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

The document does not describe a clinical study with a "test set" of patients or data in the way one would for a diagnostic algorithm or a comparative clinical trial. This submission is for a physical medical device (intermittent pneumatic compression device), not an AI/ML-based diagnostic or prognostic tool.

The "testing" performed was non-clinical (bench testing, standards compliance) rather than patient-based data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no clinical "test set" and thus no ground truth established by experts in this context.

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

Not applicable, as there was no clinical "test set" requiring adjudication.

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. This is not an AI-assisted diagnostic device, and no MRMC study was performed or described.

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

Not applicable. This is a physical device, not an algorithm, and the concept of "standalone performance" for an algorithm does not apply. The device's performance is inherently "standalone" in its function as a compression device.

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

Not applicable in the context of a clinical test set. The "ground truth" for this submission are the established safety and performance standards (IEC, ISO) and the specifications of the legally marketed predicate device. The device is shown to meet these standards and be substantially equivalent to the predicate.

8. The sample size for the training set

Not applicable. This is a physical device submission and does not involve AI/ML models requiring a "training set."

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

Not applicable. No training set was used.

Summary

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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 (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" (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 (800) 638-2041 or (301) 796-7100 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:

Deep vein thrombosis and pulmonary embolism prophylaxis.

Foot Compression

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

1. Circulation enhancement.
1. Deep vein thrombosis prophylaxis.
1. Edema-Acute.
1. Edema-Chronic.
1. Extremity pain incident to trauma or surgery.
1. Leg Ulcers.
1. 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: fdalanding@sohu.com Telephone: +86-27-59263677 Fax: +86-27-59368637

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: fdalanding@sohu.com Telephone: +86-27-59263677 Fax: +86-27-59368637

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 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.
1. Deep vein thrombosis prophylaxis.
1. Edema-Acute.
1. Edema-Chronic.
1. Extremity pain incident to trauma or surgery.
1. Leg Ulcers.
1. 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, footcuffs, air supply tubes, power line	Pump controller, thigh cuffs, calf cuffs, foot cuffs,battery, air supply tubes, power line
Ingress of Water	Ordinary	Ordinary
protection
Compression type	thigh cuffs & calf cuffs: Sequential, Gradientfoot cuffs: Uniform	thigh cuffs & calf cuffs: Sequential, Gradientfoot cuffs: Uniform
Compression time	Single thigh cuffs: 6s CompressionDual thigh cuffs: 12s CompressionSingle calf cuffs: 4s CompressionDual calf cuffs: 8s CompressionSingle foot cuffs: 2.5s CompressionDual foot cuffs: 5s Compression	Single thigh cuffs: 5.5s CompressionDual thigh cuffs: 11s CompressionSingle calf cuffs: 4s CompressionDual calf cuffs: 8s CompressionSingle foot cuffs: 2.5s CompressionDual foot cuffs: 5s Compression
Deflation time	2-3s	2-3s
Default inflatableInterval time	48s	48s
Adjustableinflatable intervaltime	24s, 48s, 60s	24s, 48s, 60s
Default Pressure	thigh cuffs & calf cuffs: 45 mmHgfoot cuffs: 130 mmHg	thigh cuffs & calf cuffs: 40 mmHgfoot cuffs: 130 mmHg
AdjustablePressure	thigh cuffs & calf cuffs: 30-60 mmHgfoot cuffs: 120-140 mmHg	thigh cuffs & calf cuffs: 30-60 mmHgfoot cuffs: 120-140 mmHg
Mode of operation	Continuous	Continuous
Application mode	Single thigh cuffs CompressionDual thigh cuffs CompressionSingle calf cuffs CompressionDual calf cuffs CompressionSingle foot cuffs CompressionDual foot cuffs Compression	Single thigh cuffs CompressionDual thigh cuffs CompressionSingle calf cuffs CompressionDual calf cuffs CompressionSingle foot cuffs CompressionDual foot cuffs CompressionSimultanous single thigh cuffs and single calfcuffs Compression
Bed Hook	Yes	Yes
Power cordstorage	Yes	Yes
Audible/VisualAlarms	Low Pressure, High Pressure, Pump Error,Valve Error, System Error,	No garment, Pump Error, Valve Error,Temperature Error, Software Error, System Error,High Pressure, Low Pressure, Low Battery
ControllDimensions	Length: 280mm; Width: 145mm; Height:250mm	Length: 240mm; Width: 140mm; Height: 263mm
Controll Weight	3kg	3.5kg
PowerRequirement	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
MicroprocessorControl	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.

--- End of this section ---

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).