Veinoflow SCD, LBTK-M-I 5006 is a system to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients. LBTK-M-I 5006 is indicated for Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema -Acute, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg ulcers, Venous Stasis / Venous Insufficiency.

Device Description

Veinoflow SCD, Model LBTK-M-I 5006, is a pneumatic pump system that supplies compressed air to inflate garments that are attached to a patent's lower limbs. It consists of a pump controller, specially designed inflation and deflation garments for feet and legs, air supply tubes, and power line. The inflation and deflation garments have 3 types: ① leg garments, ② calf garments, ③ foot cuffs. The system offers sequential inflation and propels the vein blood from limb to heart, therefore enhancing the blood circulation. The controller can automatically detect the external garment type, and provides pressure correspondingly. The pressure value is preset and adjustable. The controller has a self test system, when there is any error, it will alarm both in visual and audio.

AI/ML Overview

This document does not describe acceptance criteria for the performance of an AI/ML device in terms of diagnostic accuracy or clinical outcomes. Instead, it is a 510(k) summary for a medical device called "Veinoflow SCD" (Model: LBTK-M-I 5006), which is an intermittent pneumatic compression device.

The study described is focused on demonstrating substantial equivalence to a predicate device (Veinoflow SCD, Model: LBTK-M-I 5001, K123830), primarily through non-clinical testing of safety and performance characteristics. This type of regulatory submission does not typically involve the kinds of studies (e.g., multi-reader multi-case studies, standalone algorithm performance) that would be conducted for AI/ML-driven diagnostic or prognostic devices seeking to establish clinical performance.

Here's an analysis based on the provided text, addressing your questions where applicable and noting where the information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on compliance with established international standards for medical devices and demonstration that differences from the predicate device do not raise new safety or effectiveness concerns.

Acceptance Criteria (Standard / Characteristic)	Reported Device Performance (Veinoflow SCD, Model: LBTK-M-I 5006)
Electrical Safety: Conformance to ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)	Passed the tests of ANSI AAMI ES60601-1. Demonstrated to conform to the standard. Differences in controller dimensions and weight from predicate do not affect performance and do not raise new safety/effectiveness issues.
Electromagnetic Compatibility (EMC): Conformance to ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests	Passed the tests of IEC 60601-1-2. Demonstrated to conform to the standard. Differences in controller dimensions and weight from predicate do not affect performance and do not raise new safety/effectiveness issues.
Battery Safety: Conformance to IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems	The battery used by the proposed device has passed the test of the IEC 62133-2 standard. Difference in battery specifications (11.1V 5000mAh Lithium Ion vs. 14.8V 3100mAhr Lithium Ion for predicate) does not raise any safety or effectiveness issues as the new battery passed testing.
Biocompatibility (Cytotoxicity): Conformance to ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.	Demonstrated to conform to the standard.
Biocompatibility (Irritation and Skin Sensitization): Conformance to ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.	Demonstrated to conform to the standard.
Functional Equivalence: Differences in design features (e.g., controller dimensions, weight, default inflation interval, battery) must not affect the fundamental performance or indications for use, and must not raise new questions of safety or effectiveness.	Controller Dimensions/Weight: Length: 185mm; Width: 165mm; Height: 250mm; Weight: 2.5kg (vs. Predicate: Length: 240mm; Width: 140mm; Height: 263mm; Weight: 3.5kg). Conclusion: These differences don't affect performance and don't raise new safety/effectiveness issues. Default Inflatable Interval Time: 60s (vs. Predicate: 48s). Conclusion: Adjustable interval times (24s, 48s, 60s) are the same for both devices, allowing user choice. This difference doesn't raise new safety/effectiveness issues.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a "test set" in the context of AI/ML evaluation (i.e., a dataset used to evaluate diagnostic performance). The testing mentioned is for device safety and electrical performance (e.g., electrical safety, EMC, biocompatibility, battery safety) according to international standards. Therefore, information on sample size and data provenance in this context is not applicable or not provided. The provenance of the device manufacturer is China.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As noted above, this device is not an AI/ML diagnostic device requiring an expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI-assisted device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" in this context is compliance with established engineering and safety standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and the functional specifications of the device as tested against these standards. It's not a clinical ground truth for a diagnostic outcome.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the AI/ML sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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February 9, 2022

Dalian Labtek Science & Development Co., Ltd. % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China

Re: K213313

Trade/Device Name: Veinoflow SCD (Model: LBTK-M-I 5006) Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: January 5, 2022 Received: January 10, 2022

Dear Doris Dong:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 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

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Indications for Use

510(k) Number (if known) K213313

Device Name Veinoflow SCD

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary [As required by 21 CFR 807.92]

1. Submission Information

510(k) Number:	K213313
Date:	September 8th, 2021
Type of 510(k) Submission:	Traditional 510(k)
Owner:	Dalian Labtek Science & Development Co., Ltd.1-18-17, Liandong Street, Advanced Equipment Manufacturing IndustryPark Economic-Technological Development Zone, Dalian, LiaoningChina, 116085Tel: +86-411-84548445E-mail: sales001@labtek-med.com
Contact:	Doris Dong[Consultant, from Shanghai CV Technology Co., Ltd.]Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 ChinaE-mail: doris.d@ceve.org.cnTel: 86 21-31261348 / Fax: 86 21-57712250

2. Device Description

Proprietary Name:	Veinoflow SCD
Model:	LBTK-M-I 5006
Common Name:	Intermittent Pneumatic Compression Device
Classification Name:	Compressible limb sleeve
Regulation Number:	21 CFR 870.5800
Product Code:	JOW
Device Class:	II
Review Panel:	Cardiovascular
Device Description:	Veinoflow SCD, Model LBTK-M-I 5006, is a pneumatic pump system that suppliescompressed air to inflate garments that are attached to a patent's lower limbs. Itconsists of a pump controller, specially designed inflation and deflation garments forfeet and legs, air supply tubes, and power line. The inflation and deflation garmentshave 3 types: ① leg garments, ② calf garments, ③ foot cuffs.
	The system offers sequential inflation and propels the vein blood from limb to heart,therefore enhancing the blood circulation. The controller can automatically detect theexternal garment type, and provides pressure correspondingly. The pressure value ispreset and adjustable. The controller has a self test system, when there is any error, itwill alarm both in visual and audio.
Indications for use:	All the leg garments, calf garments and foot cuffs are packaged in pairs. Thecontroller can function properly in both situations either when connected to a onesingle leg garment/calf garment/foot cuff or one pair of leg garments/calfgarments/foot cuffs, giving the end user more flexibility for prophylaxis options.Veinoflow SCD, LBTK-M-I 5006 is a system to prevent DVT (Deep VeinThrombosis) by improving the blood velocity of patients. LBTK-M-I 5006 isindicated for Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema- Acute Edema - Chronic Extremity Pain Incident to Trauma or Surgery Leg ulcers

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Venous Stasis / Venous Insufficiency.

3. Predicate Device

The Veinoflow SCD (LBTK-M-I 5006) is equivalent to the following:

Predicate Device	Manufacturer	510(k) Number
Veinoflow SCD, LBTK-M-I 5001	Dalian Labtek Science & Development Co., Ltd.	K123830

4. Substantial Equivalence to Predicate device

More Detailed comparison data is included in "Section 10 - Substantial Equivalence Discussion" of this 510(k) submission.

	New Device	Predicate Device	Remark
510(k) Number	To be assigned	K123830	--
Device Name	Veinoflow SCD	Veinoflow SCD	--
Model	LBTK-M-I 5006	LBTK-M-I 5001	--
Manufacturer	Dalian Labtek Science &Development Co., Ltd.	Dalian Labtek Science &Development Co., Ltd.	Same
Product Code	JOW	JOW	Same
Class	II	II	Same
Indications foruse	Veinoflow SCD, LBTK-M-I 5006 is asystem to prevent DVT (Deep VeinThrombosis) by improving the bloodvelocity of patients. LBTK-M-I 5006is indicated for CirculationEnhancement, Deep Vein ThrombosisProphylaxis, Edema -Acute, Edema -Chronic, Extremity Pain Incident toTrauma or Surgery, Leg ulcers,Venous Stasis / Venous Insufficiency.	Veinoflow SCD system, ModelLBTK-M-I 5001 is a system toprevent DVT (Deep Vein Thrombosis)by improving the blood velocity ofpatients. LBTK-M-I 5001 is indicatedfor Circulation Enhancement, DeepVein Thrombosis Prophylaxis, Edema-Acute, Edema - Chronic, ExtremityPain Incident to Trauma or Surgery,Leg ulcers, Venous Stasis / VenousInsufficiency.	Same
Prescription orOTC	Prescription	Prescription	Same
Components	Pump controller, multi-cavity leggarments, calf garments, foot cuffs,battery, air tubes and power line	Pump controller, multi-cavitythigh-calf garments, calf garments,foot cuffs, battery, air supply tubes,power line	Same
CompressionType	Leg garments & Calf garments:Sequential, GradientFoot Cuffs: Uniform	Thigh-calf garments & calf garments:Sequential, GradientFoot Cuffs: Uniform	Same
Case Materials	ABS	ABS	Same
ControllerDimensions	Length: 185mm; Width: 165mm;Height: 250mm	Length: 240mm; Width: 140mm;Height: 263mm	SimilarNote 1
ControllerWeight	2.5kg	3.5kg
Deflation time	2~3s	2~3s	Same
Default	60s	48s	Similar
			Note 2
inflatableinterval time
Adjustableinflatableinterval time	24s, 48s, 60s	24s, 48s, 60s	Same
DefaultPressure	Leg garments & Calf garments:40mmHgFoot Cuffs: 130mmHg	Thigh-calf garments & calf garments:40mmHgFoot Cuffs: 130mmHg	Same
Adjustablepressure	Leg garments & Calf garments:30~~60mmHg (10mmHg per step)Foot Cuffs: 120~~140mmHg(10mmHg per step)	Thigh-calf garments & calf garments:30~~60mmHg (10mmHg per step)Foot Cuffs: 120~~140mmHg(10mmHg per step)	Same
Mode ofOperation	Continuous	Continuous	Same
Bed Hook	Yes	Yes	Same
Power CordStorage	Yes	Yes	Same
Power Cord	Hospital Grade Plug	Hospital Grade Plug	Same
PowerRequirement	AC 100-240V, 50/60 Hz	AC 100-240V, 50/60 Hz	Same
Battery	DC11.1V 5000mAh, Lithium Ion	14.8V, 3100mAhr, Lithium Ion	SimilarNote 3
Shipping Unit	Each	Each	Same
Standards	ISO 10993-5, ISO 10993-10,IEC 60601-1, and IEC 60601-1-2	ISO 10993-5, ISO 10993-10,IEC 60601-1, and IEC 60601-1-2	Same
Non-sterile	Non-sterile	Non-sterile	Same
MicroprocessorControl	Yes	Yes	Same

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Summary of the technological characteristics of the device compared:

Note 1:

The weight, dimensions and appearance of the proposed device are different from the predicate device K123830, these differences don't affect the performance of the device, and the proposed device has passed the tests of ANSI AAMI ES60601-1 and IEC 60601-1-2. Therefore, these differences don't raise any new safety and effectiveness issues.

Note 2:

The default inflation interval of the proposed device is 60s, and the default inflation interval of the predicate device is 48s. However, the adjustable inflation interval time value of the proposed device and predicate device is the same (24s, 48s, 60s), and the user can adjust the inflation interval time as needed. Therefore, the difference in the default inflation interval time doesn't raise any safety and effectiveness issues.

Note 3:

The battery used is different from the predicate device, but the battery used by the proposed device has passed the test of the IEC 62133-2 standard. Therefore, this difference doesn't raise any safety or effectiveness issues.

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5. Non-clinical Testing

The conclusions drawn from the non-clinical testing below demonstrate that the Veinoflow SCD is substantially equivalent to the predicate device K123830. The Veinoflow SCD has been tested and conforms to international consensus standards:

Electrical safety:

· ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD);

EMC:

• ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances --Requirements And Tests;

Additional safety testing:

· IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems;

Biocompatibility testing:

· ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity. (Biocompatibility)

· ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility)

6. Conclusion

The data included in this submission demonstrate that the modified Veinoflow SCD (Model: LBTK-M-I 5006) is substantially equivalent to the cleared primary predicate device, the K123830. Veinoflow SCD (Model: LBTK-M-I 5001).

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).