(139 days)
Not Found
No
The description focuses on automated protocols and control systems, which are not inherently AI/ML. There is no mention of AI, ML, or related terms, nor any description of training or test data sets typically associated with AI/ML development.
Yes
The device is described as an "autotransfusion system" for "recovery of blood," "washing of the processed blood," and "pre-operative sequestration," which are all therapeutic interventions for the patient. Its intended uses are for "intraoperative and postoperative recovery of blood" and "pre-operative sequestration," further indicating its therapeutic purpose.
No
Explanation: The device is described as an autotransfusion system used for intraoperative and postoperative recovery of blood, washing, and sequestration. Its function is to process blood, not to diagnose a condition or disease.
No
The device description explicitly states that the ABMS consists of both hardware and disposables, including a centrifuge, blood pump, clamps, sensors, and a user interface.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as recovering, washing, and sequestering blood from the patient during and after surgery. This is a direct interaction with the patient's blood within the context of a medical procedure, not for diagnostic testing of a sample in vitro (outside the body).
- Device Description: The description focuses on hardware components like a centrifuge, blood pump, clamps, and sensors, all designed for processing blood from the patient.
- Lack of Diagnostic Elements: There is no mention of analyzing blood components for diagnostic purposes, detecting biomarkers, or providing information about a patient's health status based on laboratory analysis. The metrics provided (Platelet Yield and Collection Efficiency) relate to the processing of the blood, not its diagnostic properties.
IVD devices are used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the therapeutic processing of blood for reinfusion into the same patient.
N/A
Intended Use / Indications for Use
The ABMS is indicated for intraoperative and postoperative recovery of blood, washing of the processed blood, and pre-operative sequestration (with indirect and direct patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.
Product codes (comma separated list FDA assigned to the subject device)
CAC
Device Description
The ABMS consists of hardware and disposables. It is an enhancement of the parent device, the Dideco Compact-A. It integrates the automated autotransfusion protocols of the STAT-P as well as adding automated sequestration protocols. The main elements of the hardware include the centrifuge, blood pump, three automatic clamps, control sensors, and a user interface (control panel). The modifications to the disposables are an increase in the thickness of the base of the bowl and a change in labeling to the new product codes.
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)
Bench and electrical (safety and EMI/EMC) testing presented in this 510(k) demonstrates that the ABMS is substantially equivalent to the Compact-A in these areas. In addition, a clinical study was conducted to compare the results obtained using automated sequestration (ABMS) with those previously submitted to FDA for the manual sequestration process. As shown in Table H-1 below, results for the PRP collected with the ABMS in the automatic mode were similar to those using the manual mode. The lower standard deviations for the ABMS results demonstrate more consistency and overall reproducibility in product collection than that observed with the manual sequestration process.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
PRP Platelet Yield (1011): ABMS Mean 0.79, Manual Process Mean 0.75; ABMS SD 0.29, Manual Process SD 0.32. PRP Platelet Collection Efficiency (%): ABMS Mean 69.2, Manual Process Mean 69.4; ABMS SD 17.6, Manual Process SD 20.3.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K940519, K884564, K910991, K963758, K963759
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).
0
DEC 16 1988
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APPENDIX H
- 2017-02-04 11:12:13
・・・
510(k) Summary
Dideco S.p.A. Abbreviated 510(k) 7/29/98 Autologous Blood Management System (ABMS)
1
510(k) Summary Dideco S.p.A. Autologous Blood Management System (per 21 CFR 807.92)
SPONSOR/APPLICANT 1.
Mr. Luigi Vecchi Contact: Dideco, S.p.A. via Statale 12 Nord, 86 I-41037 Mirandola (MO), Italy 011 39 535 298 11 Telephone: 011 39 535 252 29 Facsimile:
DEVICE NAME 2.
| Proprietary Name: | Autologous Blood Management System (ABMS) |
|---|---|
| Common/Usual Name: | Autotransfusion Device |
| Classification Names: | Autotransfusion Apparatus |
PREDICATE DEVICES 3.
| • STAT-P | K884564 |
|---|---|
| • Compact | K910991 (under the name Shiley Therapeutic Autotransfusion System) |
| • Compact-A | K940519 |
| K963758 | |
| K963759 | |
| • AT-1000 | K Number could not be identified |
4. INTENDED USE
The ABMS is indicated for intraoperative and postoperative recovery of blood, washing of the processed blood, and pre-operative sequestration (with indirect and direct patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and Gynecology, and Urology.
2
DEVICE DESCRIPTION 5.
The ABMS consists of hardware and disposables. It is an enhancement of the parent device, the Dideco Compact-A. It integrates the automated autotransfusion protocols of the STAT-P as well as adding automated sequestration protocols. The main elements of the hardware include the centrifuge, blood pump, three automatic clamps, control sensors, and a user interface (control panel). The modifications to the disposables are an increase in the thickness of the base of the bowl and a change in labeling to the new product codes.
BASIS FOR DETERMINATION OF EQUIVALENCE 6.
Dideco S.p.A. makes the claim of substantial equivalence based on the intended use, indications for use, design, operational and technological characteristics, materials of construction, and principles of operation.
Bench and electrical (safety and EMI/EMC) testing presented in this 510(k) demonstrates that the ABMS is substantially equivalent to the Compact-A in these areas. In addition, a clinical study was conducted to compare the results obtained using automated sequestration (ABMS) with those previously submitted to FDA for the manual sequestration process. As shown in Table H-1 below, results for the PRP collected with the ABMS in the automatic mode were similar to those using the manual mode. The lower standard deviations for the ABMS results demonstrate more consistency and overall reproducibility in product collection than that observed with the manual sequestration process.
| Characteristic | ABMS | Manual
Process | |
|-------------------------------------------|------|-------------------|------|
| PRP Platelet Yield (1011) | Mean | 0.79 | 0.75 |
| | SD | 0.29 | 0.32 |
| PRP Platelet Collection Efficiency
(%) | Mean | 69.2 | 69.4 |
| | SD | 17.6 | 20.3 |
| Table H-1. Sequestration Results | |
|---|---|
| -- | ---------------------------------- |
A side by side comparison of the characteristics of the ABMS with cited predicate devices is provided in Table H-2.
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| Characteristic | ABMS | STAT-P | COMPACT | COMPACT-A | AT-1000 |
|---|---|---|---|---|---|
| Separation by | |||||
| centrifugation | YES | YES | YES | YES | YES |
| Separation chamber: bowl | YES | YES | YES | YES | YES |
| Available bowl sizes (ml) | 55, 125, | ||||
| 175, 225 | 55, 125, | ||||
| 175, 225 | 55, 125, | ||||
| 175, 225 | 55, 125, | ||||
| 175, 225 | 125, 225, 375 | ||||
| Blood source for PPP/PRP | bag or | ||||
| patient | NA | bag or | |||
| patient | bag or | ||||
| patient | bag or | ||||
| patient | |||||
| Fully and semi-automatic | |||||
| processing | YES | YES | NO | YES | YES |
| Air detector | YES | YES | YES | YES | YES |
| Buffy coat detector | YES | YES | YES | YES | YES |
| Pre-programmable | YES | YES | NO | YES | YES |
| Reprogrammable | YES | YES | NO | YES | YES |
| Tools required for bowl | |||||
| installation | NO | YES | NO | NO | YES |
| Integral vacuum unit | NO | YES | NO | NO | YES |
| Dimensions (inches) | 17 x 22 x | ||||
| 18 | 34 x 20 x | ||||
| 31 | 17 x 22 x | ||||
| 18 | 17 x 22 x 18 | 17 x 31 x 48 | |||
| Weight (approx. in lbs.) | 73 | 262 | 73 | 73 | 265 |
| Identical tubing diameter | YES | YES | YES | YES | YES |
| Blood pump speed | |||||
| (range in ml/min) | 25-1000 | 25-1000 | 25-1000 | 25-1000 | 0-1000 |
| Centrifuge speed (range in | |||||
| RPM) | 1500-5600 | 1500-4800 | 1500-5600 | 1500-5600 | 2400-5600 |
| PPP collection parameters | 50 ml/min | ||||
| 5600 RPM | NA | 50 ml/min | |||
| 5600 RPM | 50 ml/min | ||||
| 5600 RPM | 50-100 ml/min | ||||
| 5600 RPM | |||||
| PRP collection parameters | 50 ml/min | ||||
| 2400 RPM | NA | 50 ml/min | |||
| 2400 RPM | 50 ml/min | ||||
| 2400 RPM | 50-100 ml/min | ||||
| 2400 RPM | |||||
| Operating Phases | |||||
| PRIME mode | YES | YES | YES | YES | YES |
| WASH mode | YES | YES | YES | YES | YES |
| EMPTY mode | YES | YES | YES | YES | YES |
| RETURN mode | YES | YES | YES | YES | YES |
| CONCentrate mode | YES | YES | YES | YES | YES |
| CONTinuous operation | YES | YES | YES | YES | YES |
| BQW (Better Quality | |||||
| Wash feature) | YES | NO | YES | YES | YES (Pulse |
| Wash Mode) |
Table H-2. Comparison of the ABMS with Predicate Devices
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font.
DEC 1 6 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dideco, S.P.A. c/o Ms.Rosina Robinson Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
K982650 Re : Dideco Autologous Blood Management System (ABMS) Requlatory Class: II (Two) Product Code: CAC November 11, 1998 Dated: November 12, 1998 Received:
Dear Ms. Robinson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). You may, therefore, market the device, subject to the general controls provisions of The general controls provisions of the Act include the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
5
Page 2 - Ms. Rosina Robinson
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 Other general information on your responsibilities under 807.97) . . the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
6
K 98,265 510(k) Number (if known):
Device Name: Dideco Autologous Blood Management System (ABMS)
Indications For Use:
The ABMS is indicated for intraoperative recovery of blood, washing of blood collected in the post-operative period, and pre-operative sequestration (with indirect and direct patient connection). Typical clinical applications of autotransfusion include the following surgical specialties:
- Cardiovascular
- Orthopedics
- Thoracic
- Transplant Surgery
- Emergency (Trauma)
- Neurosurgery
- Obstetrics and gynecology
- Urology
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sue L. Cooper
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K 98267 510(k) Number _
Prescription Use Use Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
Dideco S.p.A. Abbreviated 510(k) 7/29/98 Autologous Blood Management System (ABMS)