(128 days)
Not Found
No
The device description details a pneumatic pump system with preset and adjustable pressure, automatic garment type detection, and a self-test system. There is no mention of AI, ML, or any learning or adaptive capabilities based on patient data or other inputs beyond basic automation. The performance studies focus on electrical safety, EMC, and biocompatibility, not on algorithmic performance metrics typically associated with AI/ML.
Yes
The device is described as a system to prevent DVT by improving blood velocity and is indicated for conditions like DVT prophylaxis, edema, and venous insufficiency, all of which are therapeutic purposes.
No
The device is described as a pneumatic pump system designed to prevent Deep Vein Thrombosis (DVT) by improving blood velocity and enhancing circulation, not for diagnosing medical conditions. Its indications for use are prophylactic and therapeutic (e.g., DVT prophylaxis, edema, leg ulcers), not diagnostic.
No
The device description clearly states it is a "pneumatic pump system" consisting of a "pump controller, specially designed inflation and deflation garments, air supply tubes, and power line," which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent DVT and treat various conditions by improving blood velocity through pneumatic compression. This is a therapeutic and preventative physical intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is a pneumatic pump system that applies external pressure to the limbs. It does not involve analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Veinoflow SCD does not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JOW
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.
All the leg garments, calf garments and foot cuffs are packaged in pairs. The controller can function properly in both situations either when connected to a one single leg garment/calf garment/foot cuff or one pair of leg garments/calf garments/foot cuffs, giving the end user more flexibility for prophylaxis options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs (feet and legs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing was conducted to demonstrate substantial equivalence to the predicate device K123830. The tests performed include:
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) and ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization. (Biocompatibility).
The conclusion is that the Veinoflow SCD is substantially equivalent to the predicate device K123830 based on these tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
Indications for Use
510(k) Number (if known) K213313
Device Name Veinoflow SCD
Indications for Use (Describe)
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.
| 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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3
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 Industry | |
| Park Economic-Technological Development Zone, Dalian, Liaoning | |
| China, 116085 | |
| Tel: +86-411-84548445 | |
| E-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 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 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 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. | |
| Indications for use: | All the leg garments, calf garments and foot cuffs are packaged in pairs. The |
| controller can function properly in both situations either when connected to a one | |
| single leg garment/calf garment/foot cuff or one pair of leg garments/calf | |
| garments/foot cuffs, giving the end user more flexibility for prophylaxis options. | |
| 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 |
4
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 for | |||
| use | 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. | Veinoflow SCD system, Model | ||
| LBTK-M-I 5001 is a system to | |||
| prevent DVT (Deep Vein Thrombosis) | |||
| by improving the blood velocity of | |||
| patients. LBTK-M-I 5001 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. | Same | ||
| Prescription or | |||
| OTC | Prescription | Prescription | Same |
| Components | Pump controller, multi-cavity leg | ||
| garments, calf garments, foot cuffs, | |||
| battery, air tubes and power line | Pump controller, multi-cavity | ||
| thigh-calf garments, calf garments, | |||
| foot cuffs, battery, air supply tubes, | |||
| power line | Same | ||
| Compression | |||
| Type | Leg garments & Calf garments: | ||
| Sequential, Gradient | |||
| Foot Cuffs: Uniform | Thigh-calf garments & calf garments: | ||
| Sequential, Gradient | |||
| Foot Cuffs: Uniform | Same | ||
| Case Materials | ABS | ABS | Same |
| Controller | |||
| Dimensions | Length: 185mm; Width: 165mm; | ||
| Height: 250mm | Length: 240mm; Width: 140mm; | ||
| Height: 263mm | Similar | ||
| Note 1 | |||
| Controller | |||
| Weight | 2.5kg | 3.5kg | |
| Deflation time | 2~3s | 2~3s | Same |
| Default | 60s | 48s | Similar |
| Note 2 | |||
| inflatable | |||
| interval time | |||
| Adjustable | |||
| inflatable | |||
| interval time | 24s, 48s, 60s | 24s, 48s, 60s | Same |
| Default | |||
| Pressure | Leg garments & Calf garments: | ||
| 40mmHg | |||
| Foot Cuffs: 130mmHg | Thigh-calf garments & calf garments: | ||
| 40mmHg | |||
| Foot Cuffs: 130mmHg | Same | ||
| Adjustable | |||
| pressure | 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 of | |||
| Operation | Continuous | Continuous | Same |
| Bed Hook | Yes | Yes | Same |
| Power Cord | |||
| Storage | Yes | Yes | Same |
| Power Cord | Hospital Grade Plug | Hospital Grade Plug | Same |
| Power | |||
| Requirement | AC 100-240V, 50/60 Hz | AC 100-240V, 50/60 Hz | Same |
| Battery | DC11.1V 5000mAh, Lithium Ion | 14.8V, 3100mAhr, Lithium Ion | Similar |
| Note 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 |
| Microprocessor | |||
| Control | Yes | Yes | Same |
5
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.
6
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).