B&J DVT Foot Garments, Models 820 Series
Device Facts
| Record ID | K201547 |
|---|---|
| Device Name | B&J DVT Foot Garments, Models 820 Series |
| Applicant | B&J Manufacturing , Ltd. |
| Product Code | JOW · Cardiovascular |
| Decision Date | Sep 18, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.5800 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The B&J DVT Foot Garments, Models 820 Series are external pneumatic compression devices intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
Device Story
B&J DVT Foot Garments (820 Series) are external pneumatic compression sleeves designed for use with compatible pneumatic pump systems. The garments consist of inflatable bladders that, when connected to a pump, apply sequential or intermittent pressure to the patient's foot. This compression collapses veins, forcing blood flow toward the heart; subsequent deflation allows veins to refill with oxygenated blood. Used in clinical settings to prevent DVT and PE in at-risk patients. The device is operated by healthcare professionals. Output is mechanical compression; clinical benefit is reduced risk of venous thromboembolism.
Clinical Evidence
No clinical data. Substantial equivalence is supported by bench testing only, including biocompatibility, bladder burst, leak testing, and pressure cyclic testing with B&J pneumatic pumps.
Technological Characteristics
Materials: nylon loop, polyurethane foam, polyester tricot, TPU film, PVC tube, nylon velcro, polyester/cotton binding, nylon thread, polyester loop, TPU connector. Operation: external pneumatic compression (intermittent or sequential). Form factor: foot garments in medium (13") and large (16") sizes. Energy source: external pneumatic pump. Connectivity: none (mechanical interface).
Indications for Use
Indicated for patients at risk for deep vein thrombosis (DVT) and pulmonary embolism (PE) formation.
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
- VasoPress Reprocessed DVT Garment (K112838)
Reference Devices
Submission Summary (Full Text)
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September 18, 2020
B&J Manufacturing Ltd. % Fu Ailing Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1713A, 17F, Block A, Time Square, Xili Town Shenzhen, Guangdong 518055 China
Re: K201547
Trade/Device Name: B&J DVT Foot Garments, Models 820 Series Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: August 15, 2020 Received: August 21, 2020
Dear Fu Ailing:
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.
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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 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 medical devices and radiation-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.
for Fernando Aguel 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)
K201547
Device Name
B&J DVT Foot Garments, Models 820 Series
### Indications for Use (Describe)
The B&I DVT Foot Garments, Models 820 Series are external pneumatic compression devices intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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510(k) Submission
### 510(k) Summary
[As required by 21 CFR 807.92]
### 1. Date Prepared [21 CFR807.92 (a) (1)]
June 20, 2020
### 2. Submitter's Information [21 CFR807.92 (a) (1)]
Name of Sponsor: B&J Manufacturing Ltd.
Address: Room 701 & 101, Building 24, Block B, Yuanshan Industrial Zone, Shangcun Community, Gongming Street, Guangming District, Shenzhen, 518106 China
Contact Name: Billy Yu
| Telephone No.: | +86-0755-88210239 |
|----------------|-------------------|
| Fax No.: | +86-0755-88210289 |
Email Address: vl_billy@126.com
Email Address: yl_billy@126.com
### 3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
Trade Name/Model: B&J DVT Foot Garments, Models 820 Series DVT Foot Garments 820 Series Common Name: Classification Name: Sleeve, Limb, Compressible Regulation Number: 21 CFR 870.5800 Product code: JOW Classification Panel: Cardiovascular Device Class: Il
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### 4. Identification of Predicate and Reference Devices [21 CFR 807.92(a) (3)]
The identified predicate within this submission is as follows:
The B&J DVT Foot Garments, Models 820 Series are substantially equivalent to devices. Foot Garment of VasoPress Reprocessed DVT Garment (K112838 decided on 11/10/2011) in commercial distribution by Compression Therapy Concepts, Inc. 35 James Way Eatontown, NJ 07724-2272.
The identified reference devices within this submission are as follows:
Compression Therapy Concepts, Inc., VasoPress DVT System, Pump Model VP500D has been cleared by FDA through 510(k) No. K061814 (Decision Date - November 30, 2006).
Caremed Supply, Inc., VesoFlow Lite DVT Compression Device has been cleared by FDA through 510(k) No. K181217 (Decision Date - August 5, 2018).
### 5. Description of the Device [21 CFR 807.92(a) (4)]
The 820 series of DVT foot garments are compression devices. When the devices are attached to a pump system, they provide sequentially gradient pressure to a patient foot for the prevention of deep vein thrombosis (DVT). When the compression sleeve is inflated, the veins collapse which forces blood to move upward toward the heart. After compression is complete, the sleeves deflate which allows the veins to reopen and bring oxygenated blood to the foot.
820 series includes 820M, 820L, 820MSQ, 820LSQ. Model variations are distinguished by characters. 820 means foot. M means medium size; L means large size. No SQ means intermittent devices; SQ means sequential devices. For example, 820MSQ means the foot garment is with medium size, and used for a sequential pump.
### 6. Intended Use [21 CFR 807.92(a)(5)]
The B&J DVT Foot Garments, Models 820 Series are external pneumatic compression devices intended to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation.
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### 7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Series | Model | Size | Description | Type | Materials |
|--------------------------------------------------------|--------|------|-------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 820 Series (DVT<br>Prophylaxis<br>Garment<br>For Foot) | 820M | 13" | Foot Garment,<br>Medium | Intermittent | (nylon loop, polyurethane foam,<br>polyester tricot, TPU film, PVC<br>tube, nylon velcro, polyester &<br>cotton binding, nylon thread,<br>polyester loop, TPU connector) |
| | 820L | 16" | Foot Garment,<br>Large | | |
| | 820MSQ | 13" | Foot Garment,<br>Medium | Sequential | For single air chamber, air cannot<br>be filled by gradient. |
| | 820LSQ | 16" | Foot Garment,<br>Large | | |
### 820 Series
### 8. Subtantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
### 8.1 Intended use:
| ID | Comparison<br>Item | Proposed Device<br>DVT Foot Garments<br>(820 Series) | Predicate Device<br>VasoPress Reprocessed<br>DVT Garment<br>(Foot) | |
|----|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 1 | 510(K) No. | To be assigned | K112838 | |
| 2 | Intended Use | The B&J DVT Foot Garments,<br>Models 820 Series are<br>external pneumatic<br>compression devices<br>intended to lower the risk of<br>deep vein thrombosis (DVT)<br>and resulting pulmonary<br>embolism (PE) in patients who<br>may be at risk for thrombosis<br>formation. | The DVT Garment is an<br>external pneumatic<br>compression device intended<br>to lower the risk of deep vein<br>thrombosis (DVT) and<br>resulting pulmonary embolism<br>(PE) in patients who may be at<br>risk for thrombosis formation. | |
| 3 | Type of use | Prescription Use | Prescription Use | |
| ID | Comparison Item | Proposed Device<br>DVT Foot Garments<br>(820 Series) | Predicate Devices<br>Vaso Press DVT Foot Garments<br>(Reprocessed DVT Foot Garment) | Explanation of<br>Difference |
| 1 | Model | 820M | Reprocessed DVT<br>Foot Garment | The Model difference doesn't affect<br>the substantial equivalence with the<br>predicate. |
| | | 820L | Reprocessed DVT<br>Foot Garment | |
| | | 820MSQ | Reprocessed DVT<br>Foot Garment | |
| | | 820LSQ | Reprocessed DVT<br>Foot Garment | |
| 2 | Size | 13" | 13" | Same |
| | | 16" | 16" | |
| 3 | Type | Foot Garment,<br>Medium | Foot Garment,<br>Medium | Same |
| | | Foot Garment,<br>Large | Foot Garment,<br>Large | |
| 4 | Material | nylon loop, polyurethane foam, polyester tricot, TPU film, PVC<br>tube, nylon velcro, polyester & cotton binding, nylon thread,<br>polyester loop, TPU connector | nylon loop, polyurethane foam, polyester tricot, TPU film, PVC tube, nylon<br>velcro, polyester & cotton binding, nylon thread, TPU connector | According to the polyester tricot, the<br>polyester loop doesn't affect the<br>substantial equivalence with the<br>predicate. |
### Table 1 Intended Use Comparison
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0VT Foot Garments 820 Serie
## 510(k) Submission
## 8.2 Comparison table
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# 0VT Foot Garments 820 Series
## 510(k) Submission
| seconds/48seconds | 12 seconds/48seconds | 12 seconds/48seconds | Same |
|-------------------|----------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 120mmHg+10/-5mmHg | 120mmHg+10/-5mmHg | 80mmHg+/-10% | Different but same as Reference<br>Device K061814 (Foot: 80-120) or<br>K181217 (Foot: 120) |
| Intermittent | Sequential | Intermittent | For 820 without SQ, the sequencing<br>is the same as that of the predicate.<br>For 820 with SQ, the sequencing is<br>different with that of the predicate, but<br>the 820 with SQ, and the predicate<br>are independently used with their<br>specific pumps, which doesn't affect<br>the substantial equivalence with the<br>predicate according to the<br>performance test |
510(k) Summary
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It is clear that the technological characteristics differences discussed above do not affect the substantial equivalence of 820 series with their predicates.
### 8.3 Non-clinical Testing
The following safety and performance tests were conducted to assess 820 series of garments.
- 0 Biocompatibility
- O Performance
- Bladder burst
- Leak test
- Pressure cyclic test with the B&J pneumatic pumps
All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria and intended use.
No clinical testing was used to support the decision of substantial equivalence.
### 9. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, B&J Manufacturing Ltd. concludes that:
- The intended use of 820 series is identical to that of the predicate devices.
- The technological characteristic differences between 820 series and the predicate devices do not affect the substantial equivalence, so no new risk is raised.
- Demonstrated by the safety and performance tests, the characteristics of 820 series are substantially equivalent to those of the predicate devices.
