← Product Code [KOC](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOC) · K964041 # CUTANEOUS COMPRESSION DEVICE FOR USE IN HEMODIALYSIS (K964041) _Robert R. Stevens · KOC · Jan 30, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOC/K964041 ## Device Facts - **Applicant:** Robert R. Stevens - **Product Code:** [KOC](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOC.md) - **Decision Date:** Jan 30, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5820 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for Use Cutaneous Compression Device for Use in Hemodialysis. ## Device Story Device functions as cutaneous compression aid for hemodialysis patients; applies pressure to vascular access site to facilitate hemostasis post-dialysis. Used in clinical hemodialysis settings; operated by healthcare professionals. Provides mechanical compression to minimize bleeding; replaces manual pressure application. Benefits patient by reducing time required for site stabilization and potential for hematoma formation. ## Clinical Evidence Bench testing only. ## Technological Characteristics Mechanical cutaneous compression device. Materials and dimensions not specified. Non-powered, manual operation. No software or electronic components. ## Regulatory 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. ## Predicate Devices - Cutaneous Compression Device for General Hospital Use ([K955270](/device/K955270.md)) - Cutaneous Compression Device for Use in Hemodialysis ([K951973](/device/K951973.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} JAN 30 1997 K964041 X. Summary of Safety and Effectiveness 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. - 13 - --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOC/K964041](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KOC/K964041) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com