(91 days)
Not Found
No
The summary describes a dialysis solution, a chemical product, and makes no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is used as a dialysis solution in Continuous Renal Replacement Therapy, which is a medical treatment.
No
The "Intended Use / Indications for Use" states that Accusol Solutions are "indicated for use as dialysis solutions in Continuous Renal Replacement Therapy," which is a treatment, not a diagnostic procedure.
No
The device description clearly states it is a "bicarbonate based solution," which is a chemical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as dialysis solutions in Continuous Renal Replacement Therapy." This describes a therapeutic treatment administered to a patient, not a test performed on a sample taken from a patient to diagnose or monitor a condition.
- Device Description: The description states it's a "bicarbonate based solution used in continuous renal replacement therapies." This further reinforces its role as a treatment agent.
- Lack of IVD Characteristics: The document lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Image processing, AI/ML, or imaging modalities, which are often associated with certain types of IVDs.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
Accusol Solutions are administered to the patient for treatment, not used to test a sample from the patient.
N/A
Intended Use / Indications for Use
Accusol Solutions are indicated for use as dialysis solutions in Continuous Renal Replacement Therapy.
Product codes
78 KPO
Device Description
Accusol Dialysis Solution is a bicarbonate based solution used in continuous renal replacement therapies
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
AUG 2 7 2004
510(K) SUMMARY
:
| Submitter's Name: | David E. Curtin, RAC |
|---|---|
| Address: | 1620 Waukegan Rd. MPGR-A2E |
| Phone: | (847) 473-6079 |
| Fax: | (847) 473-6952 |
| Contact: | David E. Curtin |
| Date Prepared: | 5/26/04 |
| Trade Name: | Accusol Dialysis Solution |
| Common Name: | Dialysis Solution |
| Classification Name: | Dialysate Concentrate for Hemodialysis (Liquid or Powder) per |
| 21 CFR 876.5820 Hemodialysis System and Accessories. The | |
| Product/Classification code is KPO. | |
| Equivalent Predicate: | PrismaSate Dialysis Solutions, K013448 |
| Gambro Renal Products | |
| Premixed Dialysate for Hemodiafiltration, K910270 | |
| Baxter Healthcare Corporation | |
| BIASOL Liquid Concentrate, K895199 | |
| Baxter Healthcare Corporation | |
| Device Description: | Accusol Dialysis Solution is a bicarbonate based solution used |
| in continuous renal replacement therapies | |
| Intended Use: | Accusol Solutions are indicated for use as dialysis solutions in |
| Continuous Renal Replacement Therapy |
1
K~L'UZ.8 paag 20+2
Summary of the Technological Characteristics Compared to the Predicate Device: Accusol Dialysis Solution is formulated of the same solution components to the same quantitative levels as dialysis solutions used to formulate the PrismaSate and BIASOL products. The Accusol Dialysis Solution container system is similar in design to the PrismaSate Dialysis Solution container system and to the materials of construction and closure system of the Premixed Dialysate for Hemodiafiltration products.
Additional Information Requested by FDA:
None to date
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or flowing lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2004
David E. Curtin, RAC Associate Director, Regulatory Affairs Baxter Healthcare Corporation Renal Division 1620 Waukegan Road MCGAW PARK IL 60085
Re: K041428
Trade/Device Name: Accusol Dialysis Solution Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: August 19, 2004 Received: August 20, 2004
Dear Mr. Curtin:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becalling is the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard) the enactment date of the Medical Device Amendments, or to conninered prior to may 20, 1978, is eacordance with the provisions of the Federal Food, Drug, devices that have been rochise in assee approval of a premarket approval application (PMA). alle Costictle Act (110c) that do novice, subject to the general controls provisions of the Act. The r ou may, therefore, thanks of the Act include requirements for annual registration, listing of general controls provisions of wactice, labeling, and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (600 a00 v). Existing major regulations affecting your device can be it may be subject to additions, 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 Flease be advised that I Dri 3 issualite somplies with other requirements of the Act that I DA has made a actestions administered by other Federal agencies. You must of any I ederal statutes and roguinents, including, but not limited to: registration and listing compry with an the rece I requirements, as 801); good manufacturing practice requirements as set (21 CFR Part 007), acoming (2) cegulation (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (QS) res (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Scetion 510(k) This letter will allow you to begin marketing; your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of y premarket notification. The FDA inding of substantial equivalities and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFK Part 801), please
r on If you desire specific advice for your device on our laboling ought and on the regulation
contact the Office of Compliance at one of the following numbers, based on the regul number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the promotion and the regulation entitled, "Masbranding
Office of Compliance at (301) 594-4639. Also, please note the sencral Office of Compliance at (301) 394-4037. Associated on any obtain. Other general
by reference to premarket notification" (21CFR Part 807.97) you may obtained from the Divisio by reference to premarket noniticals under the Act may be obtained from the Division of Strall
information on your responsibilities under the Act may be obtained from the (80 information on your responsibilities three at its tall-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-first (800) 638-2041 or Manufacturers, International and Colisumer resistance at to received.
(301) 443-6597 or at its Internet address http://www.fda.gov/odch/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) Number (if known): _KOH 1428
Device Name: Accusol Dialysis Solution
Indications for Use:
Accusol Solutions are indicated for use as dialysis solutions in Continuous Renal Replacement Therapy.
ﺍﻟﻤﺴﺘﺸﻴﺮ ﺍﻟﻤﺘ
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office Device Evaluation (ODE)
Prescription Use__
(Per 21 CFR 801.109
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1/2/96)
David A. Bryson
(Division Sign-Off) Division of Reproductive, Abd and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________