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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the SH14 Hemoconcentrator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for each performance metric in a pass/fail format. Instead, it indicates that the results of the tests "met established specifications" or "met established specifications." For comparative purposes, it also states that data collected show that functional and biocompatibility parameters exhibited by the currently marketed predicate devices (Sorin Group USA HC1400 Maxi and DHF 0.6) apply to the SH14.

Therefore, the table below will list the tests performed and the general outcome as reported. The implication is that the performance of the SH14 was either equivalent to or within the established specifications of the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility:
Hemocompatibility (ISO 10993-1.1995 & FDA May 1, 1995 Memorandum)	Met established specifications and applied to SH14
Cytotoxicity (ISO 10993-1.1995 & FDA May 1, 1995 Memorandum)	Met established specifications and applied to SH14
Irritation (ISO 10993-1.1995 & FDA May 1, 1995 Memorandum)	Met established specifications and applied to SH14
Acute Systemic Toxicity (ISO 10993-1.1995 & FDA May 1, 1995 Memorandum)	Met established specifications and applied to SH14
Mutagenicity (ISO 10993-1.1995 & FDA May 1, 1995 Memorandum)	Met established specifications and applied to SH14
Sterility & Safety:
Sterility	Met established specifications and demonstrated effective production techniques
Pyrogenicity	Met established specifications and demonstrated effective production techniques
ETO residuals	Met established specifications
Package integrity	Met established specifications
In Vitro Functional Performance:
Mechanical integrity (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990")	Met established specifications
Priming Volume (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990")	Met established specifications
Pressure Drop (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990")	Met established specifications
Ultrafiltration rate (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990")	Met established specifications
Sieving coefficient (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990")	Met established specifications
Hemolysis (Guidance for "conventional and high permeability hemodyalizers, August 7, 1990")	Met established specifications
Shipping carton protection	Passed basic testing, capable of adequate protection

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific "sample size" for the in vitro tests (e.g., number of SH14 devices tested for priming volume). It generally states "a complete battery of tests were carried out" and "in vitro testing were carried out."

Regarding data provenance:

Country of Origin: Not explicitly stated for each test, but the submitter is Sorin Group Italia S.r.I. (Italy).
Retrospective or Prospective: These were laboratory "in vitro" tests, implying they were prospective tests conducted specifically for this submission. The biocompatibility tests were performed on the SH14, aged up to three years ("accelerated aging").

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and is not provided. The "ground truth" for device performance in this context is based on objective, measurable physical, chemical, and biological properties evaluated through standardized laboratory tests, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation by multiple readers) to establish a consensus ground truth. Here, the "truth" is derived directly from quantitative measurements in laboratory settings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data, and the AI's impact on their performance is being evaluated. This device is a medical device for hemoconcentration, not a diagnostic AI.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the studies described are standalone performance studies of the device itself (not an algorithm in the typical AI sense). The "in vitro test results" and "biocompatibility test results" sections detail these standalone performance evaluations against established specifications and comparison with predicate devices.

7. The Type of Ground Truth Used

The "ground truth" in this context is the objective performance of the device as measured by established scientific and engineering methods, guided by:

Standardized Test Methods: ISO 10993-1.1995 for biocompatibility and "Guidance for the content of premarket notifications for conventional and high permeability hemodyalizers, August 7, 1990" for in vitro functional performance.
Predicate Device Performance: The functional and biocompatibility parameters of the Sorin Group USA HC1400 Maxi and DHF 0.6 served as a comparative benchmark, implying that the SH14's performance should be substantially equivalent to these legally marketed devices.

8. The Sample Size for the Training Set

This information is not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" for a physical medical device like the SH14 Hemoconcentrator in the context of AI.

Summary

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K081313

SH14 HemoconcentratorSorin 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 Nord41037 Mirandola (MO) Italy
	NOV 19 2008
CONTACT PERSON:	Luigi VecchiPhone: 011 39 0535 29811Fax: 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 SealedDialysate System
PREDICATE DEVICES:	Gambro HC 14R Hemoconcentrator (K951311)hereinafter referred to as HC1400 MaxiDideco DHF 0.6 Hemoconcentrator (K021732)
DEVICE DESCRIPTION:

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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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.

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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.

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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:

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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Regulation Number and Section

§ 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.”