(114 days)
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No
The summary does not mention AI, ML, image processing, or any other indicators of AI/ML technology. The device description and intended use are simple and do not suggest complex algorithmic processing.
No
A cutaneous compression device is used for physical support and is not typically considered a therapeutic device that treats or cures a disease or condition. Its function is to apply pressure, often for hemostasis after a procedure like hemodialysis.
No
The device is described as a "Cutaneous Compression Device for Use in Hemodialysis," which is a therapeutic or supportive device, not one used for diagnosis.
No
The summary describes a "Cutaneous Compression Device," which inherently implies a physical device used for compression. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Cutaneous Compression Device for Use in Hemodialysis." This describes a physical device used externally on the body to apply pressure.
- Device Description: The description reiterates that it's a "Cutaneous Compression Device."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such activity.
- Predicate Devices: The predicate devices listed are also "Cutaneous Compression Devices," which are not IVDs.
Therefore, this device falls under the category of a medical device used for physical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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JAN 3 0 1997
Summary of Safety and Effectiveness x.
යාවාර්ති බැලි ...
i
| Classification Name: | Accessories, Hemodialysis |
|---|---|
| 21 C.F.R. § 876.5820 (1994). | |
| Common/Usual Name: | Cutaneous Compression Device for Use in |
| Hemodialysis. | |
| Proprietary Name: | At present, no proprietary name has been chosen for this |
| device. | |
| Establishment Registration: | Mr. Robert R. Stevens has submitted an application for |
| establishment registration in accordance with the | |
| requirements of 21 C.F.R. § 807.20 (1994). He has been | |
| assigned Owner/Operator Number 9020052. | |
| Classification: | Under Section 513 of the Federal Food, Drug, and |
| Cosmetic Act, this device is classified into Class II. | |
| Performance Standards: | As of the date of this Premarket Notification submission, |
| no Performance Standards have been established for this | |
| device under Section 514 of the Federal Food, Drug, and | |
| Cosmetic Act. As such, no actions have been taken to | |
| comply with Section 514 Performance Standards. | |
| Labeling: | Proposed labeling is included in this submission. |
| Substantial Equivalence: | This device is substantially equivalent to the following |
| legally-marketed devices ("Predicate Devices") in terms | |
| of safety, effectiveness, and intended use: | |
| Product: Cutaneous Compression Device for General | |
| Hospital Use | |
| Manufacturer: Concurrent Device Manufacturing, Inc. | |
| 510(k) Number: K955270 | |
| Substantial Equivalence Date: August 8, 1996 | |
| Product: Cutaneous Compression Device for Use in | |
| Hemodialysis | |
| Manufacturer: Concurrent Device Manufacturing, Inc. | |
| 510(k) Number: K951973 | |
| Substantial Equivalence Date: Determined to be Class | |
| I Exempt device under 21 C.F.R. § 876.5820, as evidenced | |
| by letter from Lillian Yin dated June 13, 1995. |
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