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 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.

AI/ML Overview

The provided text is a 510(k) submission for a medical device (B&J DVT Foot Garments, Models 820 Series), which is a type of premarket notification to the FDA. It does not describe a study involving an AI/Machine Learning algorithm, human readers, or image analysis. Instead, it focuses on demonstrating the substantial equivalence of the DVT garments to previously cleared predicate devices through non-clinical performance and safety testing.

Therefore, many of the requested criteria for describing an acceptance study for an AI/ML device cannot be extracted from this document, such as:

Table of acceptance criteria and reported device performance for an AI/ML device: The document discusses performance tests for the physical DVT garments (bladder burst, leak, pressure cyclic test), not AI/ML performance metrics like sensitivity, specificity, or AUC.
Sample size for test set and data provenance (e.g., country of origin, retrospective/prospective): Not applicable for a physical device.
Number of experts and their qualifications for ground truth: Not applicable for a physical device.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable, as there's no AI involved.
Standalone (algorithm-only) performance: Not applicable.
Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable. The "ground truth" here is physical performance specifications.
Sample size for training set/How ground truth for training set was established: Not applicable, as this is not an AI/ML device.

However, I can extract the acceptance criteria and study information relevant to this specific medical device (DVT Garments), even though it doesn't pertain to an AI/ML system as your prompt implies:

Device Description and Purpose:
The B&J DVT Foot Garments, Models 820 Series, are external pneumatic compression devices. They are designed to lower the risk of deep vein thrombosis (DVT) and resulting pulmonary embolism (PE) in patients at risk for thrombosis formation. When attached to a pump system, they provide sequentially gradient pressure to a patient's foot.

Study Type:
This is a non-clinical testing study to assess the safety and performance of the physical device and demonstrate substantial equivalence to predicate devices, not an AI/ML performance study.

1. Table of acceptance criteria and the reported device performance

The document states: "All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria and intended use."

However, the specific "predefined acceptance criteria" values are not explicitly detailed in the provided text for each test. We know the types of tests performed:

Acceptance Criterion (Implicit)	Reported Device Performance (Implicitly Met)
Biocompatibility: Device materials must be biocompatible.	"All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria..."
Bladder Burst: The bladder must withstand burst pressure.	"All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria..."
Leak Test: The device must not leak.	"All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria..."
Pressure Cyclic Test: The device must maintain pressure over cycles with a B&J pneumatic pump.	"All the test results demonstrate 820 series of foot garments meet the requirements of its predefined acceptance criteria..."

Note: The document only lists the types of tests performed and broadly states that the acceptance criteria were met. It does not provide the specific numerical acceptance thresholds (e.g., "bladder must withstand X mmHg," "leakage rate must be less than Y mL/min," "must withstand Z cycles").

2. Sample sized used for the test set and the data provenance:

Sample Size: Not specified in the provided text. The document refers to "the following safety and performance tests were conducted," implying a sample of prototypes or production units were tested, but exact numbers are not given.
Data Provenance: Not explicitly stated, however, the DVT garments are manufactured by B&J Manufacturing Ltd. in Shenzhen, China. Tests would likely have been conducted in a validation or manufacturing setting. The data is non-clinical/engineering test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of an AI/ML device. This refers to engineering and material testing, where "ground truth" is established by manufacturing specifications, international standards, and test methodologies.

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

Not applicable. This is for an AI/ML device where human readers adjudicate discrepancies. For physical device testing, results are typically objective measurements against predefined engineering specifications.

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:

No. This is not an AI/ML device, so an MRMC study comparing human reader performance with and without AI assistance was not performed.

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

No. This is not an AI/ML algorithm. The performance tests are on the physical device itself.

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

Engineering Specifications and Standards: For physical devices like these DVT garments, the "ground truth" for performance is established through predefined engineering specifications, material properties, and relevant international or industry standards (e.g., for bursting strength, leak rates, cyclic fatigue). It's objective measurement against a benchmark.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. As above, no training set for an AI/ML algorithm is involved.

Summary

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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.

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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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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)]

6. Intended Use [21 CFR 807.92(a)(5)]

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7. Technological Characteristics [21 CFR 807.92(a)(6)]

Series	Model	Size	Description	Type	Materials
820 Series (DVTProphylaxisGarmentFor Foot)	820M	13"	Foot Garment,Medium	Intermittent	(nylon loop, polyurethane foam,polyester tricot, TPU film, PVCtube, 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 cannotbe 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	ComparisonItem	Proposed DeviceDVT Foot Garments(820 Series)	Predicate DeviceVasoPress ReprocessedDVT Garment(Foot)
1	510(K) No.	To be assigned	K112838
2	Intended Use	The B&J DVT Foot Garments,Models 820 Series areexternal pneumaticcompression devicesintended to lower the risk ofdeep vein thrombosis (DVT)and resulting pulmonaryembolism (PE) in patients whomay be at risk for thrombosisformation.	The DVT Garment is anexternal pneumaticcompression device intendedto lower the risk of deep veinthrombosis (DVT) andresulting pulmonary embolism(PE) in patients who may be atrisk for thrombosis formation.
3	Type of use	Prescription Use	Prescription Use
ID	Comparison Item	Proposed DeviceDVT Foot Garments(820 Series)	Predicate DevicesVaso Press DVT Foot Garments(Reprocessed DVT Foot Garment)	Explanation ofDifference
1	Model	820M	Reprocessed DVTFoot Garment	The Model difference doesn't affectthe substantial equivalence with thepredicate.
		820L	Reprocessed DVTFoot Garment
		820MSQ	Reprocessed DVTFoot Garment
		820LSQ	Reprocessed DVTFoot 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, PVCtube, nylon velcro, polyester & cotton binding, nylon thread,polyester loop, TPU connector	nylon loop, polyurethane foam, polyester tricot, TPU film, PVC tube, nylonvelcro, polyester & cotton binding, nylon thread, TPU connector	According to the polyester tricot, thepolyester loop doesn't affect thesubstantial equivalence with thepredicate.

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 ReferenceDevice K061814 (Foot: 80-120) orK181217 (Foot: 120)
Intermittent	Sequential	Intermittent	For 820 without SQ, the sequencingis the same as that of the predicate.For 820 with SQ, the sequencing isdifferent with that of the predicate, butthe 820 with SQ, and the predicateare independently used with theirspecific pumps, which doesn't affectthe substantial equivalence with thepredicate according to theperformance 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.

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).

Indications for Use

Indications for Use (Describe)

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510(k) Summary

1. Date Prepared [21 CFR807.92 (a) (1)]

2. Submitter's Information [21 CFR807.92 (a) (1)]

3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]

4. Identification of Predicate and Reference Devices [21 CFR 807.92(a) (3)]

5. Description of the Device [21 CFR 807.92(a) (4)]

6. Intended Use [21 CFR 807.92(a)(5)]

7. Technological Characteristics [21 CFR 807.92(a)(6)]

820 Series

8. Subtantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

8.1 Intended use:

Table 1 Intended Use Comparison

510(k) Submission

8.2 Comparison table

0VT Foot Garments 820 Series

510(k) Submission

8.3 Non-clinical Testing

9. Conclusion [21 CFR 807.92(b) (3)]

§ 870.5800 Compressible limb sleeve.

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