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510(k) Data Aggregation
(176 days)
The Reusable Blood Pressure Cuff is an accessory used in conjunction with noninvasive blood pressure measurement systems. The cuff is non-sterile and reusable in infant, pediatric but not neonatal, and adult sizes.
The proposed device is an accessory used in conjunction with noninvasive blood pressure measurement systems, and wrap around the patient's limb. The cuff is non-sterile and reusable. The model difference of the proposed device includes bladder type, tube, color, joint model and size.
The given text is a 510(k) Summary for a Reusable Blood Pressure Cuff, which is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices. This document focuses on proving that the new device is as safe and effective as existing products, primarily through non-clinical testing and comparison to predicate devices, rather than an extensive study proving new performance criteria for a novel device or an AI algorithm.
Therefore, many of the requested details, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "sample size for training set," are not applicable to this type of regulatory submission and product. The device is a physical medical accessory, not an AI algorithm.
I will extract the available and relevant information.
Acceptance Criteria and Device Performance for Reusable Blood Pressure Cuff (K171889)
The acceptance criteria for the Reusable Blood Pressure Cuff (K171889) are established by demonstrating compliance with recognized international standards and substantial equivalence to predicate devices. The study conducted was primarily non-clinical testing to verify design specifications and biological compatibility.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Aspect | Standard/Requirement | Reported Device Performance | Comments on Performance |
|---|---|---|---|
| Basic Safety and Essential Performance | IEC 80601-2-30: 2013 | Complies | |
| Biocompatibility - Cytotoxicity | ISO 10993-5: 2009 | Complies | |
| Biocompatibility - Irritation & Skin Sensitization | ISO 10993-10: 2010 | Complies | |
| Intended Use Equivalence | Equivalent to Predicate Device 1 (K133117) & Predicate Device 2 (K152468) | Stated as same or slight differences that do not impact safety/effectiveness | The proposed devices include similar intended uses (accessory for noninvasive blood pressure measurement systems, non-sterile, reusable, various sizes). Differences like extended tube configurations or slight size variations are deemed not to affect safety or effectiveness. |
| Device Class | Class II (Regulatory) | Class II | |
| Product Code | DXQ | DXQ | |
| Regulation Number | 21 CFR 870.1120 | 21 CFR 870.1120 | |
| Patient Populations | Adult (for internal bladder), Infant/Pediatric/Adult (for integrated bladder) | Matches Predicate Devices' populations | The proposed device expands to include infant/pediatric populations for integrated bladder cuffs, which is aligned with Predicate Device 2. |
| Tube Configuration | One or two tube | Two tube configuration as well as one tube | Broader than Predicate 1 (one tube only), but matched by Predicate 2 (one or two tubes). Not considered a safety/effectiveness issue. |
| Bladder Type | Internal Bladder / Integrated Bladder | Both are offered by the proposed device | Predicate 1 uses Internal Bladder, Predicate 2 uses Integrated Bladder. The proposed device offers both variations. |
| Reusable | Yes | Yes | |
| Sterile | No | No | |
| Pressure Range | 0-300mmHg | 0-300mmHg | Matches Predicate Devices. |
| Material | Compliant with Biocompatibility Standards | Polyester (internal bladder), TPU leather with nylon (integrated bladder) | Different materials than predicate devices, but compliance with ISO 10993-5 and -10 confirmed. |
| Size Range (Internal Bladder) | e.g., Small adult: 17-22cm; Large Adult: 30-42 cm | Stated as "included in the range of the predicate device 1" | User manual indicates clear selection based on size. Not considered a safety/effectiveness issue. |
| Size Range (Integrated Bladder) | e.g., Infant: 9-14.8cm; Child: 13.8-21.5cm; Thigh: 45-56.5cm | Stated as "different to that of predicate device 2," but "slight" | User manual indicates clear selection based on size. Not considered a safety/effectiveness issue. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the non-clinical tests (e.g., how many cuffs were tested for biocompatibility or performance). The data provenance is not detailed beyond the manufacturer being Suzhou Minhua Medical Apparatus Supplies Co., LTD in China, implying testing was likely conducted in China. The study refers to "non-clinical tests" and "test results" and "laboratory tests," which are inherently prospective for the specific devices being tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. The device is a physical medical accessory, and the "ground truth" for its performance is established by compliance with international engineering and biocompatibility standards, not by expert consensus on diagnostic interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies involving interpretation (e.g., imaging reads) where there can be differing opinions among experts. This product's evaluation is based on objective measurements against engineering and biological standards.
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
This information is not applicable. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of data/images, often with AI assistance. This device is a blood pressure cuff and does not involve "readers" or "AI assistance" in that context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical blood pressure cuff, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Reusable Blood Pressure Cuff is compliance with:
- Engineering Standards: IEC 80601-2-30: 2013 (Medical Electrical Equipment - Basic Safety And Essential Performance Of Automated Non-Invasive Sphygmomanometers).
- Biocompatibility Standards: ISO 10993-5: 2009 (Tests For In Vitro Cytotoxicity) and ISO 10993-10: 2010 (Tests For Irritation And Skin Sensitization).
- Substantial Equivalence: Comparison to legally marketed predicate devices (K133117 and K152468) regarding intended use, principles of operation, materials, and performance specifications.
8. The sample size for the training set
This information is not applicable. "Training set" refers to data used to train algorithms, primarily in machine learning or AI. This device is a physical medical accessory.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this physical device.
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