(164 days)
No
The summary describes a mechanical device for hemoconcentration and does not mention any computational or algorithmic components, let alone AI/ML.
Yes
The device is described as a "Hemoconcentrator" intended for use in "cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit," which is a therapeutic intervention.
No
The device is a hemoconcentrator, used to restore physiological hematocrit in cardiopulmonary bypass circuits. It is a treatment device, not for diagnosing conditions.
No
The device description clearly states it is a physical device ("hollow fiber type hemoconcentrator consisting of an external transparent housing... and a fiber bundle"). The performance studies also describe in vitro testing of physical properties.
Based on the provided information, the Dideco DHF Hemoconcentrator 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 cardiopulmonary bypass circuits. This is a therapeutic procedure performed directly on the patient's blood outside the body, but as part of a larger medical intervention.
- Device Description: The description details a device that physically processes blood (hollow fiber type hemoconcentrator).
- Lack of IVD Characteristics: There is no mention of the device being used to analyze samples (blood, tissue, etc.) to provide diagnostic information about a patient's condition. IVDs are typically used to detect, measure, or identify substances or characteristics in a sample to aid in diagnosis, monitoring, or screening.
The device is clearly intended for a therapeutic purpose related to blood processing during surgery, not for diagnostic testing.
N/A
Intended Use / Indications for Use
The Dideco DHF Hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemconcentrator depends on the protocol being used and required filtration speed. The device is intended to be used for six hours or less.
Product codes
78 KDI
Device Description
The Dideco DHF Hemoconcentrator is a hollow fiber type hemoconcentrator 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.
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)
NONCLINICAL TEST RESULTS:
Applicable tests were carried out in accordance with the requirements of ISO 10993-1:1997 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of raw materials. Tests were performed on devices accelerated aged to an equivalent of five years real time aging. Sterility, pyrogenicity, ETO residuals and package integrity testing were also conducted. The results of this testing met established specifications.
IN VITRO TEST RESULTS:
In vitro testing was carried as out in accordance with the requirements of the "Guidance for the Content of Premarket Notifications for Conventional and High permeability Hemodialyzers" Guidance for industry and CDRH reviewers issued on August 7, 1998 by CDRH and on the EN 1283 "Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits" issued on April 1996 when applicable. The following tests were performed to demonstrate the compliance of the DHF hemoconcentrators with safety and effectiveness requirements: priming volume, pressure drop, ultrafiltration rate, sieving coefficient, mechanical integrity, blood trauma, including measurement of plasma free hemoglobin and index of hemolysis. The results of these tests carried out on the DHF 0.6 and DHF 0.2 Hemoconcentrators aged to 5 years met established specifications. Data collected show that functional and biocompatibility parameters exhibited by the currently marketed Cobe HC 700 Midi and HPH 400 apply to the DHF 0.6 and DHF 0.2 hemoconcentrators.
CONCLUSION:
The new series of DHF hemoconcentrators show comparable or even better performances with respect to their related predicate devices as demonstrated by the in vitro test results presented in the submission. 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. Therefore the DHF 0.2 hemoconcentrator are substantially equivalent to the predicate devices Cobe HC 700 Midi and Hemocor HPH 400 respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cobe HC 700 Midi Hemoconcentrator (K003023), Hemocor HPH 400 Hemoconcentrator (K923139)
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.”
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KO21732
Page 1 of 2
DHF Hemoconcentrator Dideco S.p.A.
Abbreviated 510(k) May 24, 2002
4 2002 NOV
| SUBMITTER: | Dideco S.p.A.
86. Via Statale 12 Nord
41037 Mirandola (MO) Italy |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Luigi Vecchi
Phone: 011 39 0535 29811
Fax: 011 39 0535 25229 |
| DATE PREPARED: | May 24, 2002 |
| DEVICE TRADE NAME: | DHF Hemoconcentrator
available in the DHF Series:
DHF 0,2 Hemoconcentrator: Dideco Newborn-Infant
Hemoconcentrator
DHF 0.6 Hemoconcentrator: Dideco Pediatric/Small Adult
Hemoconcentrator |
| COMMON NAME: | Hemoconcentrator |
| CLASSIFICATION NAME: | Dialyzer, High permeability With or Without Sealed
Dialysate System |
| PREDICATE DEVICE: | Cobe HC 700 Midi Hemoconcentrator (K003023)
Hemocor HPH 400 Hemoconcentrator (K923139) |
510(k) SUMMARY
DEVICE DESCRIPTION:
The Dideco DHF Hemoconcentrator is a hollow fiber type hemoconcentrator 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 Dideco DHF Hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemconcentrator depends on the protocol being used and required filtration speed. 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 DHF 0.2 Hemoconcentrator and for the Hemoconcentrator (K923139) predicate device. The design, operating principles and control mechanisms are exactly the same for the DHF 0.6 Hemoconcentrator and for the Cobe HC 700 Midi Hemoconcentrator (K003023) predicate device. The
1
Iqs 201-2
DHF Hemoconcentrator Dideco S.p.A.
Abbreviated 510(k) May 24, 2002
basic function of all the above mentioned hemoconcentrators is the removal of excess from patient's blood during or after cardiopulmonary bypass procedures resulting in fluid hemoconcentration and restoring of patient's physiological hematocrit. Diluted blood is drawn, from the patient, inside the fibers of the device while plasma water is removed across the semi-permeable hollow fibers from the blood pathway to the filtrate side. The DHF hemoconcentrators are ethylene oxide sterilized and have a nonpyrogenic fluid path. They are for single use only.
NONCLINICAL TEST RESULTS:
Applicable tests were carried out in accordance with the requirements of ISO 10993-1:1997 and the FDA May 1, 1995 Memorandum on the use of the ISO 10993 standard for biocompatibility testing of raw materials. Tests were performed on devices accelerated aged to an equivalent of five years real time aging. Sterility, pyrogenicity, ETO residuals and package integrity testing were also conducted. The results of this testing met established specifications.
IN VITRO TEST RESULTS:
In vitro testing was carried out in accordance with the requirements of the "Guidance for the Content of Premarket Notifications for Conventional and High permeability Hemodialyzers" Guidance for industry and CDRH reviewers issued on August 7, 1998 by CDRH and on the EN 1283 "Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits" issued on April 1996 when applicable. The following tests were performed to demonstrate the compliance of the DHF hemoconcentrators with safety and effectiveness requirements: priming volume, pressure drop, ultrafiltration rate, sieving coefficient, mechanical integrity, blood trauma, including measurement of plasma free hemoglobin and index of hemolysis. The results of these tests carried out on the DHF 0.6 and DHF 0.2 Hemoconcentrators aged to 5 years met established specifications. Data collected show that functional and biocompatibility parameters exhibited by the currently marketed Cobe HC 700 Midi and HPH 400 apply to the DHF 0.6 and DHF 0.2 hemoconcentrators.
CONCLUSION:
The new series of DHF hemoconcentrators show comparable or even better performances with respect to their related predicate devices as demonstrated by the in vitro test results presented in the submission. 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. Therefore the DHF 0.2 hemoconcentrator are substantially equivalent to the predicate devices Cobe HC 700 Midi and Hemocor HPH 400 respectively.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
od and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Dideco S.p.A. c/o Barry Sall, RAC Senior Regulatory Consultant PAREXEL International Corp. 195 West Street WALTHAM MA 02451-1163
Re: K021732
Trade/Device Name: Dideco DHF Hemoconcentrator Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: September 18, 2002 Received: September 19, 2002
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 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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
Image /page/2/Picture/11 description: The image shows a partial view of a seal or emblem. The visible portion includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular pattern around the edge. The central part of the emblem features a stylized design, possibly representing a symbol or logo associated with the department.
3
Page 2
This letter will allow you to begin marketing your device as described in your 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:
| 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 Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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
DHF Hemoconcentrator Dideco S.p.A.
510(k) Number (if known):
Device Name. Dideco DHF Hemoconcentrator
Indications For Use:
The Dideco DHF Hemoconcentrator is intended for use in cardiopulmonary bypass circuits for hemoconcentration and consequent restoring of patient's physiological hematocrit. The choice of hemconcentrator depends on the protocol being used and required filtration speed. The device is intended. to be used for six hours or less.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR Over-The-Counter Use _
David h. Symon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number