(101 days)
No
The summary describes a mechanical compression device and its accessories. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is intended to lower the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), indicating a therapeutic purpose.
No
Explanation: The device is described as an external pneumatic compression device intended to lower the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) by providing compression to the foot. Its function is to prevent deep vein thrombosis, not to diagnose it.
No
The device description explicitly states it is a "compression device" and "garments" that are "attached to a pump system." The performance studies include tests like "Bladder burst" and "Leak test," which are indicative of physical hardware components. The predicate and reference devices are also described as physical compression systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients who may be at risk for thrombosis formation." This is a therapeutic and preventative function, not a diagnostic one.
- Device Description: The device description explains how the garment provides external pneumatic compression to the foot to promote blood flow. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is a medical device used for physical therapy and prevention, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
JOW
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot
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:
- Biocompatibility
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
4
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.
5
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| Series | Model | Size | Description | Type | Materials |
|---|---|---|---|---|---|
| 820 Series (DVT | |||||
| Prophylaxis | |||||
| Garment | |||||
| For Foot) | 820M | 13" | Foot Garment, | ||
| Medium | Intermittent | (nylon loop, polyurethane foam, | |||
| polyester tricot, TPU film, PVC | |||||
| tube, nylon velcro, polyester & | |||||
| cotton binding, nylon thread, | |||||
| polyester loop, TPU connector) | |||||
| 820L | 16" | Foot Garment, | |||
| Large | |||||
| 820MSQ | 13" | Foot Garment, | |||
| Medium | Sequential | For single air chamber, air cannot | |||
| be filled by gradient. | |||||
| 820LSQ | 16" | Foot Garment, | |||
| Large |
820 Series
8. Subtantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended use:
| ID | Comparison
Item | Proposed Device
DVT Foot Garments
(820 Series) | Predicate Device
VasoPress Reprocessed
DVT Garment
(Foot) | |
|----|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| 1 | 510(K) No. | To be assigned | K112838 | |
| 2 | Intended 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. | The DVT Garment is an
external pneumatic
compression device 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. | |
| 3 | Type of use | Prescription Use | Prescription Use | |
| ID | Comparison Item | Proposed Device
DVT Foot Garments
(820 Series) | Predicate Devices
Vaso Press DVT Foot Garments
(Reprocessed DVT Foot Garment) | Explanation of
Difference |
| 1 | Model | 820M | Reprocessed DVT
Foot Garment | The Model difference doesn't affect
the substantial equivalence with the
predicate. |
| | | 820L | Reprocessed DVT
Foot Garment | |
| | | 820MSQ | Reprocessed DVT
Foot Garment | |
| | | 820LSQ | Reprocessed DVT
Foot Garment | |
| 2 | Size | 13" | 13" | Same |
| | | 16" | 16" | |
| 3 | Type | Foot Garment,
Medium | Foot Garment,
Medium | Same |
| | | Foot Garment,
Large | Foot Garment,
Large | |
| 4 | Material | nylon loop, polyurethane foam, polyester tricot, TPU film, PVC
tube, nylon velcro, polyester & cotton binding, nylon thread,
polyester loop, TPU connector | nylon loop, polyurethane foam, polyester tricot, TPU film, PVC tube, nylon
velcro, polyester & cotton binding, nylon thread, TPU connector | According to the polyester tricot, the
polyester loop doesn't affect the
substantial equivalence with the
predicate. |
Table 1 Intended Use Comparison
6
0VT Foot Garments 820 Serie
510(k) Submission
8.2 Comparison table
7
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 |
| Device K061814 (Foot: 80-120) or | |||
| K181217 (Foot: 120) | |||
| Intermittent | Sequential | Intermittent | For 820 without SQ, the sequencing |
| is the same as that of the predicate. | |||
| For 820 with SQ, the sequencing is | |||
| different with that of the predicate, but | |||
| the 820 with SQ, and the predicate | |||
| are independently used with their | |||
| specific pumps, which doesn't affect | |||
| the substantial equivalence with the | |||
| predicate according to the | |||
| performance test |
510(k) Summary
8
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.