(194 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of a hollow fiber hemoconcentrator, with no mention of AI or ML.
Yes
The device is described as restoring the patient's physiological hematocrit within cardiopulmonary bypass circuits, which is a therapeutic intervention.
No
The device description indicates it is a "hollow fiber type hemoconcentrator" used to "remove plasma water across the semi-permeable hollow fibers from the blood pathway to the filtrate side," which is a treatment function, not a diagnostic one.
No
The device description clearly outlines a physical, hollow fiber hemoconcentrator with external housing, ports, and a fiber bundle, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "hemoconcentration and consequent restoring of patient's physiological hematocrit" within a cardiopulmonary bypass circuit. This is a therapeutic procedure performed directly on the patient's blood outside the body, but as part of a life support system.
- Device Description: The description details a physical device that filters blood. It doesn't mention any components or processes related to analyzing samples of blood or other bodily fluids to diagnose a condition.
- Lack of Diagnostic Language: The text does not use any language typically associated with diagnostics, such as "diagnosis," "detection," "measurement of analytes," "in vitro," or "sample analysis."
- Performance Studies: The performance studies focus on the device's mechanical integrity, filtration capabilities, and biocompatibility – all related to its function in processing blood, not analyzing it for diagnostic purposes.
IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The SH14 Hemoconcentrator is a therapeutic device used to modify the composition of blood during a medical procedure.
N/A
Intended Use / Indications for Use
The SH14 hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemiconcentrator depends on the protocol being used and required filtration rate. The device is intended to be used for six hours of less.
Product codes
KDI
Device Description
The SH14 Hemoconcentrator is a hollow fiber type hemoconcentrator available for adult patients consisting of an external transparent housing with two filtrate ports on the cylindrical body and a fiber bundle. These fibers are bonded within the housing with polyurethane. A transparent blood header cap with a male Pos-Lock port is bonded to each end of the housing.
Diluted blood is drawn, from the patient, inside the fibers of the plasma water is removed across the semi-permeable hollow fibers from the blood pathway to the filtrate side. The SH hemoconcentrator is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.
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
adult patients
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
In vitro testing were carried out in accordance with the requirements of "Guidance for the content of premarket notifications for conventional and high permeability hemodyalizers, August 7, 1990" where applicable for providing the data necessary to demonstrate both the substantial equivalence with the predicate device and also compliant with safety and effectiveness requirements. The device was aged and tested for: Mechanical integrity, Priming Volume, Pressure Drop, Ultrafiltration rate, Sieving coefficient, Hemolysis. The results of these tests met established specifications. For comparative purposes, the same testing, when applicable, has been conducted also on the aged Sorin Group USA HC1400 Maxi predicate device and non aged SH14. The shipping carton passed the basic testing and was still capable of providing adequate protection for further handling.
Data collected show that functional and biocompatibility parameters exhibited by the currently marketed Sorin Group USA HC1400 Maxi and DHF 0.6 apply to the SH14.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
BIOCOMPATIBILITY TEST RESULTS: A complete battery of tests were carried out in accordance with the requirements of ISO 10993-1.1995 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing on the raw materials. Testing was performed on the SH14 (accelerated aging up to three years). The device was tested for Hemocompatibility, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity. Sterility, Pyrogenicity, ETO residuals and package integrity testing were also conducted. The results of the testing met established specifications.
IN VITRO TEST RESULTS: In vitro testing were carried out in accordance with the requirements of "Guidance for the content of premarket notifications for conventional and high permeability hemodyalizers, August 7, 1990" where applicable for providing the data necessary to demonstrate both the substantial equivalence with the predicate device and also compliant with safety and effectiveness requirements. The device was aged and tested for: Mechanical integrity, Priming Volume, Pressure Drop, Ultrafiltration rate, Sieving coefficient, Hemolysis. The results of these tests met established specifications. For comparative purposes, the same testing, when applicable, has been conducted also on the aged Sorin Group USA HC1400 Maxi predicate device and non aged SH14. The shipping carton passed the basic testing and was still capable of providing adequate protection for further handling.
Data collected show that functional and biocompatibility parameters exhibited by the currently marketed Sorin Group USA HC1400 Maxi and DHF 0.6 apply to the SH14.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Gambro HC 14R Hemoconcentrator (K951311), Dideco DHF 0.6 Hemoconcentrator (K021732)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”
0
| SH14 Hemoconcentrator
Sorin Group Italia S.r.I. | Abbreviated 510(k)
May 9, 2008 |
| ---------------------------------------------------- | ----------------------------------- |
|---|
510(k) SUMMARY
| SUBMITTER: | Sorin Group Italia S.r.I.
86, Via Statale 12 Nord
41037 Mirandola (MO) Italy |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------|
| | NOV 19 2008 |
| CONTACT PERSON: | Luigi Vecchi
Phone: 011 39 0535 29811
Fax: 011 39 0535 25229 |
| DATE PREPARED: | November 30, 2007 |
| DEVICE TRADE NAME: | SH14 Hemoconcentrator |
| COMMON NAME: | Hemoconcentrator |
| CLASSIFICATION NAME: | Dialyzer, High Permeability With or Without Sealed
Dialysate System |
| PREDICATE DEVICES: | Gambro HC 14R Hemoconcentrator (K951311)
hereinafter referred to as HC1400 Maxi
Dideco DHF 0.6 Hemoconcentrator (K021732) |
| DEVICE DESCRIPTION: | |
The SH14 Hemoconcentrator is a hollow fiber type hemoconcentrator available for adult patients consisting of an external transparent housing with two filtrate ports on the cylindrical body and a fiber bundle. These fibers are bonded within the housing with polyurethane. A transparent blood header cap with a male Pos-Lock port is bonded to each end of the housing.
INDICATION FOR USE:
The SH14 hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemoconcentrator depends on the protocol being used and required filtration rate. The device is intended to be used for six hours or less.
TECHNOLOGICAL CHARACTERISTICS:
The design, operating principles and control mechanisms are exactly the same for the SH14 Hemoconcentrator and Sorin Group USA HC1400 Maxi. They share similar intended use and the same design, patient population, performance characteristics, technological characteristics and manufacturing processes. The SH14 has exactly the same intended use, materials, manufacturing processes and biocompatibility of DHF 0.6 predicate. The basic function of all the above mentioned hemoconcentrators is the same. That is, the removal of excess fluid from patient's blood during or after cardiopulmonary bypass procedures resulting in hemoconcentration and restoring of patient's physiological hematocrit.
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Image /page/1/Picture/0 description: The image shows a handwritten string of characters. The string is "K081313". The characters are written in a simple, clear style, making them easily readable. The image appears to be a close-up of the handwritten string.
| SH14 Hemoconcentrator | Abbreviated 510(k) |
|---|---|
| Sorin Group Italia S.r.I. | May 9, 2008 |
Diluted blood is drawn, from the patient, inside the fibers of the plasma water is removed across the semi-permeable hollow fibers from the blood pathway to the filtrate side. The SH hemoconcentrator is ethylene oxide sterilized and has a nonpyrogenic fluid path. It is for single use only.
BIOCOMPATIBILITY TEST RESULTS:
A complete battery of tests were carried out in accordance with the requirements of ISO 10993-1.1995 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing on the raw materials. Testing was performed on the SH14 (accelerated aging up to three years). The device was tested for Hemocompatibility, Cytotoxicity, Irritation, Acute Systemic Toxicity and Mutagenicity. Sterility, Pyrogenicity, ETO residuals and package integrity testing were also conducted. The results of the testing met established specifications.
IN VITRO TEST RESULTS:
In vitro testing were carried out in accordance with the requirements of "Guidance for the content of premarket notifications for conventional and high permeability hemodyalizers, August 7, 1990" where applicable for providing the data necessary to demonstrate both the substantial equivalence with the predicate device and also compliant with safety and effectiveness requirements. The device was aged and tested for: Mechanical integrity, Priming Volume, Pressure Drop, Ultrafiltration rate, Sieving coefficient, Hemolysis. The results of these tests met established specifications. For comparative purposes, the same testing, when applicable, has been conducted also on the aged Sorin Group USA HC1400 Maxi predicate device and non aged SH14. The shipping carton passed the basic testing and was still capable of providing adequate protection for further handling.
Data collected show that functional and biocompatibility parameters exhibited by the currently marketed Sorin Group USA HC1400 Maxi and DHF 0.6 apply to the SH14.
CONCLUSIONS:
The results of in vitro studies demonstrate that the SH14 hemoconcentrator performs in a manner substantially equivalent to the predicate device. Biocompatibility studies demonstrate that the device is biocompatible according to its intended use. Additional testing has also demonstrated the effectiveness of production techniques to assure that the hemoconcentrator is sterile and non-pyrogenic.
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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2008
Sorin Group Italia S.r.I. c/o Barry Sall, RAC Principal Consultant PAREXEL Consulting 200 West Street WALTHAM MA 02451
Re: K081313
Trade/Device Name: SH14 Hemoconcentrator Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: November 13, 2008 Received: November 13, 2008
Dear Mr. Sall:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2
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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Joque M. Whang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Soring Group. The logo consists of a stylized graphic to the left of the text "SORINGROUP" in a sans-serif font. Below the text is the phrase "AT THE HEART OF MEDICAL TECHNOLOGY" in a smaller font. The logo appears to be for a medical technology company.
Sorin Group Italia S.r.I.
510(k) Number (if known): K081313
Device Name: SH14 Hemoconcentrator
Indications For Use:
The SH14 hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemiconcentrator depends on the protocol being used and required filtration rate. The device is intended to be used for six hours of less.
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helene Leuer
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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