(103 days)
The B&J DVT Calf/Thigh Garments, Models 801/830 Series are designed to increase venous blood flow in at risk patients in order to help lower the risk of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
The 801/830 series of DVT calf/thigh garments are compression devices. When the devices are attached to a pump system, they provide intermittent, sequentially gradient pressure to a patient calf/thigh 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 calf or thigh.
The provided document is a 510(k) Premarket Notification for a medical device (B&J DVT Calf/Thigh Garments, Models 801/830 Series). It's important to understand that a 510(k) submission generally aims to demonstrate substantial equivalence to a previously cleared predicate device, rather than proving safety and efficacy from scratch through extensive clinical trials as would be required for a PMA (Premarket Approval).
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission refer to the non-clinical tests performed to demonstrate that the new device performs at least as well as the predicate device regarding specific physical and functional characteristics.
Here's an analysis based on the provided text for the B&J DVT Calf/Thigh Garments:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "predefined acceptance criteria" but does not explicitly list them in a table format with corresponding performance metrics. Instead, it states that "All the test results demonstrate 801 series and 830 series garments meet the requirements of its predefined acceptance criteria and intended use."
The non-clinical tests conducted are listed as:
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials are biocompatible and do not cause adverse biological reactions. | "All the test results demonstrate... garments meet the requirements of its predefined acceptance criteria." (Implied: passed biocompatibility tests) |
| Bladder burst | The inflatable bladder within the garments can withstand specified pressure without bursting. (Specific pressure value not provided) | "All the test results demonstrate... garments meet the requirements of its predefined acceptance criteria." (Implied: passed bladder burst test) |
| Leak test | The garments do not leak air when inflated, maintaining pressure effectively. (Specific leak rate criteria not provided) | "All the test results demonstrate... garments meet the requirements of its predefined acceptance criteria." (Implied: passed leak test) |
| Pressure cyclic test with B&J pneumatic pumps | The garments can withstand repeated inflation/deflation cycles at specified pressures (e.g., 40mmHg, 45/40/30mmHg) without failure. (Specific number of cycles not provided) | "All the test results demonstrate... garments meet the requirements of its predefined acceptance criteria." (Implied: passed pressure cyclic test) |
Note on Acceptance Criteria: The document implies that the acceptance criteria for these non-clinical tests were based on established standards for similar devices or performance equivalent to the predicate devices. Specific quantitative criteria (e.g., "bladder burst pressure > X mmHg", "leakage < Y ml/min", "Z cycles without failure") are not explicitly stated in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of units/garments tested for each non-clinical test (biocompatibility, bladder burst, leak test, pressure cyclic test). It refers to "801 series and 830 series garments" generally.
- Data Provenance: The testing was conducted by B&J Manufacturing Ltd. (the manufacturer) in China. The data provenance is retrospective in the sense that the testing was completed prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of 510(k) clearance based on non-clinical testing for substantial equivalence. "Ground truth" for these engineering tests is established by calibrated instruments and predefined engineering specifications, not by expert human interpretation.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers or experts are interpreting outcomes (e.g., medical images). Here, the tests are objective engineering measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted. The document explicitly states: "No clinical testing was used to support the decision of substantial equivalence." MRMC studies are clinical in nature and involve human readers assessing diagnostic performance, which was not part of this 510(k) pathway.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the device (DVT Calf/Thigh Garments). This device is a mechanical compression garment, not an algorithm or AI. Standalone performance refers to the performance of an AI algorithm without human involvement.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is defined by:
- Engineering Specifications: e.g., the expected pressure range, acceptable leakage rates, and cycle life determined through design requirements and comparison to predicate devices.
- Material Standards: For biocompatibility, it's adherence to recognized standards for medical device materials.
This is distinct from "expert consensus," "pathology," or "outcomes data" which are typically used for establishing ground truth in clinical diagnostic or prognostic studies.
8. The Sample Size for the Training Set
This information is not applicable. The device is a mechanical medical device, not an AI or machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above. There is no training set for a mechanical device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.
September 19, 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: K201532
Trade/Device Name: B&J DVT Calf/Thigh Garments, Models 801/830 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.
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
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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 (QS) 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
B&J DVT Calf/Thigh Garments, Models 801/830 Series
Indications for Use (Describe)
The B&I DVT Calif Thigh Garments, Models 801/830 Series are designed to increase venous blood flow in at risk patients in order to help lower the risk of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
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. Date Prepared [21 CFR807.92 (a) (1)]
March 10, 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: yl_billy@126.com
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
| Trade Name/Model: | B&J DVT Calf/Thigh Garments, Models 801/830 Series |
|---|---|
| Common Name: | DVT Calf/Thigh Garments 801/830 Series |
| Classification Name: | Sleeve, Limb, Compressible |
| Regulation Number: | 21 CFR 870.5800 |
| Product code: | JOW |
| Classification Panel: | Cardiovascular |
| Device Class: | II |
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4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
Primary Predicate
K061967 - VasoQuential, Model VP530
Reference Device
K991038 - VasoPress DVT Calf Garments VP 501
5. Description of the Device [21 CFR 807.92(a) (4)]
The 801/830 series of DVT calf/thigh garments are compression devices. When the devices are attached to a pump system, they provide intermittent, sequentially gradient pressure to a patient calf/thigh 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 calf or thigh.
801 series includes 801M, 801L, 801B, 801P, 801MSQ, 801LSQ, 801BSQ and 801PSQ. 830 series includes 830M, 830L, 830B, 830MSQ, 830LSQ, 830BSQ and 830SSQ. Model variations are distinguished by characters. 801 means calf; 830 means thigh. M means medium size; L means large size; B means extra large size; P or S means small size. SQ means sequential; no SQ means intermittent. For example, 801MSQ means the calf garment is with medium size, and used for a sequential pump.
6. Intended Use [21 CFR 807.92(a)(5)]
The B&J DVT Calf/Thigh Garments, Models 801/830 Series are designed to increase venous blood flow in at risk patients in order to help lower the risk of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
7. Technological Characteristics [21 CFR 807.92(a)(6)]
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| Series | SizeRange | Model | Size | Description | Type (materials) |
|---|---|---|---|---|---|
| 801 Series (DVTProphylaxisGarmentFor Calf) | 14"-32" | 801M | 18" | Calf Garment, Medium | Intermittent (materials:nylon loop, polyster loop,polyurethane foam,polyster tricot, PVC film, |
| 801L | 24" | Calf Garment, Large | PVC tube, nylon velcro, | ||
| 801B | 32" | Calf Garment, Extra Large | polyster & cotton binding,nylon thread) For singleair chamber, air cannot befilled by gradient. | ||
| 801P | 14" | Calf Garment, Small | Sequential | ||
| 801MSQ | 18" | Calf Garment, Medium | (materials:nylon loop,polyurethane foam, | ||
| 801LSQ | 24" | Calf Garment, Large | polyster tricot, TPU film,PVC tube, nylon velcro, | ||
| 801BSQ | 32" | Calf Garment, Extra Large | polyster & cotton binding,nylon thread) For three airchambers, air can be filledby gradient. | ||
| 801PSQ | 14" | Calf Garment, Small | Intermittent (materials:nylon loop, polyster loop,polyurethane foam, | ||
| 830 Series (DVTProphylaxisGarmentFor Thigh) | 14"-42" | 830M | 29" | Thigh Garment, Medium | polyster tricot, PVC film,PVC tube, nylon velcro, |
| 830L | 36" | Thigh Garment, Large | polyster & cotton binding,nylon thread) For singleair chamber, air cannot befilled by gradient. | ||
| 830B | 42" | Thigh Garment, Extra Large | Sequential(materials:nylon loop, | ||
| 830S | 14" | Thigh Garment, Small | polyurethane foam, | ||
| 830MSQ | 29" | Thigh Garment, Medium | polyster tricot, TPU film, | ||
| 830LSQ | 36" | Thigh Garment, Large | PVC tube, nylon velcro, | ||
| 830BSQ | 42" | Thigh Garment, Extra Large | polyster & cotton binding,nylon thread) For three airchambers, air can be filledby gradient. | ||
| 830SSQ | 14" | Thigh Garment, Small |
801/830 Series
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Subtantial Equivalence [21 CFR 807.92(b) (1) and 807.92 පේ
8.1 Intended use
| 1/P50V.oSalSeries |
|---|
| 801 |
| 9between |
| Comparisonand |
| Use |
| TableTrend€14 |
| ID | ComparisonItem | Proposed DeviceDVT Calf Garments(801 Series) | Predicate DeviceVaso Press Calf Garments(VP501) |
|---|---|---|---|
| 1 | 510(K) No. | To be assigned | K991038 |
| 2 | Intended Use | The B&J DVT Calf/Thigh Garments,Models 801/830 Series are designed toincrease venous blood flow in at riskpatients in order to help lower the risk ofDeep Vein Thrombosis (DVT) andPulmonary Embolism (PE). | The Vaso Press system is anexternal pneumatic compressionsystem intended to lower the risk ofdeep vein thrombosis (DVT) inpatients whom may be at risk. |
| 3 | Type of use | Prescription Use | Prescription Use |
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able 2 Intended Use Comparison between 830 Series and VP53
| ID | ComparisonItem | Proposed DeviceDVT Thigh Garments(830 Series) | Predicate DeviceVasoQuential Thigh Garments(VP530) |
|---|---|---|---|
| 1 | 510(K) No. | To be assigned | K061967 |
| 2 | Intended Use | The B&J DVT Calf/Thigh Garments,Models 801/830 Series are designed toincrease venous blood flow in at riskpatients in order to help lower the risk ofDeep Vein Thrombosis (DVT) andPulmonary Embolism (PE). | The VasoQuential is designed toincrease venous blood flow in at riskpatients in order to help preventDeep Vein Thrombosis (DVT) andPulmonary Embolism (PE). |
| 3 | Type of use | Prescription Use | Prescription Use |
8.2 Comparison table
510(k) Summary
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DVT Calf /Thigh Garments 801/830 Serie
510(k) Submission
| ID | Comparison Item | Proposed DeviceDVT Calf Garments(801 Series) | Predicate DeviceVaso Press Calf Garments(VP501) | Explanation of Difference | s/48seconds | Same | For 801 without SQ, thepressure range is same asthat of the predicate.For 801 with SQ, thepressure range is differentbut same as ReferenceDevice K061814VESOFLOW®PLUS SQS(Calf: 45, 40 and 30mmHg) | For 801 without SQ, thesequencing is the same asthat of the predicate.For 801 with SQ, thesequencing is different withthat of the predicate, butthe 801 with SQ, and thepredicate areindependently used withtheir specific pumps, whichdoesn't the substantialequivalence with thepredicate according to theperformance test. | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Model | 801M | 801L | 801B | 801P | 801MSQ | 801LSQ | 801BSQ | 801PSQ | VP501M | VP501L | VP501B | VP501P | The Model difference doesn't affect the substantial equivalence with the predicate. |
| 2 | Size | 18" | 24" | 32" | 14" | 18" | 24" | 32" | 14" | 18" | 24" | 32" | 14" | Same |
| 3 | Type | Calf Garment, Medium | Calf Garment, Large | Calf Garment, Extra Large | Calf Garment, Small | Calf Garment, Medium | Calf Garment, Large | Calf Garment, Extra Large | Calf Garment, Small | Calf Garment, Medium | Calf Garment, Large | Calf Garment, Extra Large | Calf Garment, Small | Same |
| 4 | Material | nylon loop, polyster loop, polyurethane foam, polyster tricot, PVC film, PVC tube, nylon velcro, polyster & cotton binding, nylon thread | nylon loop, polyurethane foam, polyster tricot, TPU film, PVC tube, nylon velcro, polyster & cotton binding, nylon thread | nylon loop, polyster loop, polyurethane foam, polyster tricot, PVC film, PVC tube, nylon velcro, polyster & cotton binding, nylon thread | For 801 without SQ, the materials are the same as those of the predicate device. For 801 with SQ, no polyster loop and the PVC film is changed to TPU film, which doesn't affect the substantial equivalence with the predicate according to VP520 of K003828. |
Table 3 General Comparison between 801 Series and VP50
510(k) Summary
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0VT Calf /Thigh Garments 801/830 Serie
510(k) Submission
510(k) Summary
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DVT Calf /Thigh Garments 801/830 Serie
510(k) Submission
| ID | Comparison Item | Proposed DeviceDVT Thigh Garments(830 Series) | Predicate DeviceVaso Press Thigh Garments(VP530) | Explanation of Difference | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | Model | 830M | 830L | 830B | 830S | 830MSQ | 830LSQ | 830BSQ | 830SSQ | VP530M | VP530L | VP530M | VP530L | VP530M | VP530L | VP530M | VP530L | The Model difference doesn't affect the substantial equivalence with the predicate. |
| 2 | Size | 29" | 36" | 42" | 14" | 29" | 36" | 42" | 14" | 29" | 36" | 29" | 36" | 29" | 36" | 29" | 36" | The size difference doesn't affect the substantial equivalence with the predicate. |
| 3 | Type | Thigh Garment Medium | Thigh Garment Large | Thigh, Extra Large | Thigh Small | Thigh Garment, Medium | Thigh Garment, Large | Thigh Garment, Extra Large | Thigh Small | Thigh Garment Medium | Thigh Garment Lzarge | Thigh Garment, Medium | Thigh Garment Large | Thigh Garment, Medium | Thigh Garment Large | Thigh Garment, Medium | Thigh Garment Large | The same type and different size don't affect the substantial equivalence with the predicate. |
| 4 | Material | nylon loop, polyster loop, polyurethane foam, polyster tricot, PVC film, PVC tube, nylon velcro, polyster & cotton binding, nylon thread | nylon loop, polyurethane foam, polyster tricot, TPU film, PVC tube, nylon velcro, polyster & cotton binding, nylon thread | For 830 without SQ, the materials are the same as those of the predicate device. For 830 with SQ, no polyster loop and the PVC film is changed to TPU film, which doesn't affect the substantial equivalence with the predicate according to VP520 of K003828. |
Table 4 General Comparison between 830 Series and VP530
510(k) Summary
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VT Calf /Thigh Garments 801/830 Serie
510(k) Submission
| Inflation/deflation cycle times | |||||
|---|---|---|---|---|---|
| 5 | Inflation/deflationcycle times | 12 seconds/48seconds | 12 seconds/48seconds | 12 seconds/48seconds | Same |
| 6 | Pressure ranges | 40mmHg | 45, 40 and 30 mmHg | 40mmHg | For 830 without SQ, thepressure range is same asthat of the predicate.For 830 with SQ, thepressure range is differentbut same as ReferenceDevice K061814VESOFLOW®PLUS SQS(Thigh: 45, 40 and30mmHg) |
| 7 | Sequencing | Intermittent | Sequential | Intermittent | For 830 without SQ, thesequencing is the same asthat of the predicate.For 830 with SQ, thesequencing is different withthat of the predicate, butthe 830 with SQ, and thepredicate areindependently used withtheir specific pumps, whichdoesn't affect thesubstantial equivalencewith the predicateaccording 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 801 series and 830 series with their predicates.
8.3 Non-clinical Testing
The following safety and performance tests were conducted to assess 801 series and 830 series garments.
- O Biocompatibility
- O Performance
- Bladder burst
- Leak test
- Pressure cyclic test with the B&J pneumatic pumps
All the test results demonstrate 801 series and 830 series 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 801 series and 860 series is identical to that of the predicate devices.
- The technological characteristics differences between 801 and Vaso Press VP501, 830 and Vaso Press VP530 do not affect the substantial equivalence, so no new risk is raised.
- Demonstrated by the safety and performance tests, the characteristics of 801 series and 830 series is substantially equivalent to those of the predicate devices.
§ 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).