(125 days)
Not Found
No
The description focuses on automated fluid balance monitoring, scales for volume measurement, and safety features, with no mention of AI or ML technologies.
Yes
The device is indicated for "continuous solute and/or fluid removal in patients with acute renal failure or fluid overload" and "Therapeutic Plasma Exchange (TPE) therapies," which are treatments aimed at directly addressing and improving a patient's health condition.
No
The device is designed for therapeutic purposes (continuous solute and/or fluid removal, therapeutic plasma exchange) rather than identifying or diagnosing a disease or condition. It is an "Automated Fluid Balance Monitor" used for "renal replacement therapies or plasma therapies."
No
The device description clearly outlines hardware components such as scales, pumps, a wheeled base, and a hand-crank, indicating it is a physical medical device system, not software-only.
Based on the provided text, the Edwards Aquarius System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "continuous solute and/or fluid removal in patients with acute renal failure or fluid overload" and "Therapeutic Plasma Exchange (TPE) therapies." These are direct treatments performed on the patient's blood within the body (extracorporeal circulation), not tests performed on samples outside the body to diagnose or monitor a condition.
- Device Description: The description details a system that interacts directly with the patient's blood (extracorporeal circuit) to filter and return it. It mentions "clean blood is returned to the patient." This is a therapeutic intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the Edwards Aquarius System is a therapeutic device used for renal replacement therapy and plasma exchange, not an IVD.
N/A
Intended Use / Indications for Use
The Edwards Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) therapies.
The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.
Product codes (comma separated list FDA assigned to the subject device)
KDI
Device Description
The Edwards Aquarius System needs to be used in conjunction with a tubing set and a filter to provide Hemofiltration treatment to the patient.
The tubing set has already been the subject of a PreMarket Notification, K063293 Edwards Aqualine Sterile Tubing Sets, and the filter will be the subject of a separate PreMarket Notification, currently in preparation.
The Aquarius system is an Automated Fluid Balance Monitor, designed to be used with various extracorporeal treatments in the field of renal replacement therapies or plasma therapies. All therapies must be prescribed by a physician.
The Aquarius system is divided into three circuits: the extracorporeal (blood) circuit, the substitution/dialysate circuit and the filtrate circuit.
Toxic substances are removed by filters and clean blood is returned to the patient.
The Aquarius system allows the patient to be positioned left or right of the instrument.
The Aquarius system uses two scales to accurately measure and precisely balance filtration and substitution volumes.
Heparin may be supplied to the extracorporeal circuit via an anticoagulant pump (Heparin pump). The prescribing physician may select continuous or intermittent options.
The Aquarius protective system is designed as a 2-channel system to protect the patient from foreseeable danger.
At the back of the scale system a removable hand-crank is mounted. This can be used to manually turn the blood pump in case a pump stops.
The Aquarius system is portable. It has a wheeled base connected with a handle to move or carry the Aquarius.
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
clinical setting
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)
Electrical Safety and Electromagnetic Compatibility:
Testing has been conducted following the IEC 60601 series of standards, which are FDA recognized voluntary consensus standards.
Bench Testing:
Comparative bench testing of the Edwards Aquarius System and Baxter Accura System, using an Edwards Aqualine Sterile Tubing Set K063293, is included. This concludes that the two machines have substantially equivalent performance.
Animal Testing:
No animal testing is included.
There are no patient or patient's blood contacting materials.
Clinical Testing:
No clinical testing is included.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K021615, K993064, K981681, K946279, K973322
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
§ 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
Center for Devices and Radiological Health
KC 7032C
Page 1 of 8
1/31/2007
Edwards Lifesciences Edisonstrasse 6 85716 Unterschleissheim Germany Telephone: +49 89 95475 203 JUN - 7 2007
Image /page/0/Picture/4 description: The image shows a logo with the word "Edwards" written in a serif font at the bottom. Above the word, there is a graphic element that appears to be a stylized letter "E" or a design composed of squares and rectangles. The logo has a simple and clean design.
510(k) Summary as required by 21 CFR 807.92 (c)
Date Summary Prepared:
January 31, 2007
Owner's Name:
Fax: +49 89 95475 301
| Edwards Lifesciences Services GmbH | |
|---|---|
| Address: | Edisonstrasse 6 |
| Unterschleissheim | |
| D-85717 | |
| Germany | |
| Tel: | +49 89 95475 203 |
| Fax: | +49 89 95475 301 |
| Contact Person: | Robert Madjno |
| Director of Regulatory and Quality Affairs |
510(k) Contact Persons:
Neil R. Armstrong Regulatory Affairs Advisor MeddiQuest Limited Business and Technology Centre Bessemer Drive Stevenage SG1 2DX United Kingdom Tel: +44 1763 222505 Fax: +44 1763 222049
or
1
Robert Madino Director of Regulatory and Quality Affairs Edwards Lifesciences Services GmbH Edisonstrasse 6 85716 Unterschleissheim Germany +49 89 95475 203 Tel: +49 89 95475 301 Fax:
Type of 510(k):
Traditional
Classification Name:
High Permeability Hemodialysis Systems
78 KDI
Common/Usual Name:
Hemofiltration System
Proprietary Name:
Edwards Aquarius System
Establishment Registration Number:
The device will be manufactured for: Edwards Lifesciences Services GmbH Edisonstrasse 6 Unterschleissheim D-85717 Germany Establishment Registration Number applied for
by
MeSys GmbH Beneckallee 30 Hannover D-30419 Germany Establishment Registration Number 9680719
2
Image /page/2/Picture/1 description: The image shows handwritten text on a white background. The text includes "KC70320C", "Page 3 of 8", and the date "1/31/2007". The handwriting appears to be cursive and slightly slanted. The text is arranged in three lines, with the date at the bottom.
Substantial Equivalence:
The Edwards Aguarius system is based on product manufactured by MeSys, which has also been used as the basis for the Baxter Accura System - K021615.
The Edwards Aquarius system has been marketed and developed in Europe for six years. The software has been significantly improved from that used in the Baxter Accura System and the hardware has been similarly improved reflecting the European field experience.
The Edwards Aquarius system is substantially equivalent in design, use and materials to the:
Baxter Accura System Gambro Prisma System B. Braun Diapact
K021615 K993064, K981681, K946279 K973322
The Edwards Aquarius system is made of the same materials as the Baxter Accura System (K021615).
The Edwards Aquarius system is manufactured by the same processes as the Baxter Accura System (K021615).
Comparison of Technological Features:
| Feature | Actual Device:
Edwards Aquarius | Predicate Device A:
Baxter Accura
System,
K021615 |
|---------------------------------------|-----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Housing | Front panel | Different - repositioning |
| | Rear panel | Same, except color |
| | Interior (including card
slots) | Same, except ADU and
new BLD |
| Cart | Trolley on rollers
equipped with brakes | Same, except different
tube surface treatment |
| Computer systems | | Same |
| Display | Solid State Color
monitor | Same |
| | Monitor casing | Same |
| Motherboard | | Same, except Accura
battery |
| Master extension | Extension for ADU | Not available |
| Feature | Actual Device:
Edwards Aquarius | Predicate Device A:
Baxter Accura
System,
K021615 |
| board | | |
| Serial connector
(RS232) | Optical connector | Same |
| Power supply | | Same |
| Wiring | Cable form | Same, except ADU
connection |
| Blood pump with
rotation sensor | | Same |
| Heparin pump | Hardware and Software | Different |
| Arterial pressure
sensor | | Same |
| Prefilter pressure
sensor | | Same |
| Filtrate pressure
sensor | Membrane unit holder
Pressure transducer
Evaluation electronics
Software | Same
Same
Same with later Accura
SW ver. 2.05
Same |
| Bubble trap and
venous tube clamp | | Same |
| Blood leak detector | Housing
Evaluation electronics
Software | Same
Different, change to
SMD technology
Different, changed
values for alarm limits |
| Predilution pump | | Same |
| Filtrate pump | | Same |
| Postdilution pump | | Same |
| Substitution fluid
weighing scales | Weighing scales hooks | Different, more
ergonomic with
Aquarius |
| | Weighing device
Evaluation electronics
(18 bit converter)
Software | Same
Different, change to
SMD technology
Same |
| Filtrate weighing
scales | Weighing scales hooks | Different, more
ergonomic with
Aquarius |
| Feature | Actual Device:
Edwards Aquarius | Predicate Device A:
Baxter Accura
System,
K021615 |
| | Weighing device | Same |
| | Evaluation electronics
(18 bit converter) | Different, change to
SMD technology |
| | Software | Same |
| ADU | Pressure monitoring
and pump | Not available at
Accura |
| Heater | Mechanical structure | Same |
| | Plate heater | Same |
| | Temperature Monitor | Different, integrated to
heparin pump housing |
| | Driver and evaluation
electronics | Different, change to
SMD technology |
| | Software | Same |
| AC Power | Operating Voltage | Same |
| | Input Line Current | Same |
3
KC 70320
Page 4 of 8
1/31/2007
4
KC7032C
Page 5 of 8
1/31/2007
Description of Product:
The Edwards Aquarius System needs to be used in conjunction with a tubing set and a filter to provide Hemofiltration treatment to the patient.
The tubing set has already been the subject of a PreMarket Notification, K063293 Edwards Aqualine Sterile Tubing Sets, and the filter will be the subject of a separate PreMarket Notification, currently in preparation.
The Aquarius system is an Automated Fluid Balance Monitor, designed to be used with various extracorporeal treatments in the field of renal replacement therapies or plasma therapies. All therapies must be prescribed by a physician.
The Aquarius system is divided into three circuits: the extracorporeal (blood) circuit, the substitution/dialysate circuit and the filtrate circuit.
Toxic substances are removed by filters and clean blood is returned to the patient.
The Aquarius system allows the patient to be positioned left or right of the instrument.
5
KC70320
Page 6 of 8
1/31/2007
The Aquarius system uses two scales to accurately measure and precisely balance filtration and substitution volumes.
Heparin may be supplied to the extracorporeal circuit via an anticoagulant pump (Heparin pump). The prescribing physician may select continuous or intermittent options.
The Aquarius protective system is designed as a 2-channel system to protect the patient from foreseeable danger.
At the back of the scale system a removable hand-crank is mounted. This can be used to manually turn the blood pump in case a pump stops.
The Aquarius system is portable. It has a wheeled base connected with a handle to move or carry the Aquarius,
| Fluids Management | Low Blood Flow | Regular Blood Flow |
|---|---|---|
| Pump accuracy | ±5% | ±5% |
| Blood | 10 to 200 ml/min | 30 to 450 ml/min |
| by 2 ml/min | by 10 ml/min | |
| Pre-dilution | 0-100 to 6000 ml/h | 0-100 to 10000 ml/h |
| Post-dilution | 0-100 to 4000 ml/h | 0-100 to 10000 ml/h |
| Dialysate | 0-100 to 10000 ml/h | |
| (CVVHD only) | 0-100 to 10000 ml/h | |
| Filtrate | 0-100 to 11000 ml/h | 0-100 to 12000 ml/h |
| Net fluid loss | 0-10 to 1000 ml/h | |
| by 1 ml | 0-10 to 2000 ml/h | |
| Heparin pump accuracy | ± 0.2 ml/h | ± 0.2 ml/h |
| Heparin pump settings | 0-15 ml/h by 0.5 ml/h | 0-15 ml/h by 0.5 ml/h |
| Heparin syringe size | 30 or 50 ml | 30 or 50 ml |
| Bolus function | 0.5 to 2.5 ml by | 0.5 to 2.5 ml by |
| 0.5 ml bolus increment | 0.5 ml bolus increment | |
| Scales | Low Blood Flow | Regular Blood Flow |
| Fluid balance alarm | 20g | 50g |
| Substitution scale | 0-30kg | 0-30kg |
| capacity | (max. load: 23kg) | (max. load: 23kg) |
| Filtrate scale capacity | 0-30kg | 0-30kg |
| (max. load: 23kg) | (max. load: 23kg) | |
| Fluid warmer | Low Blood Flow | Regular Blood Flow |
Significant Physical and Performance Characteristics:
6
| Accuracy | $\pm$ 0.3 °C | $\pm$ 0.3 °C |
|---|---|---|
| Working range | Off or 35°C | |
| to 39°C by 0.5°C | Off or 35°C | |
| to 39°C by 0.5°C |
| Pressure Monitoring | |
|---|---|
| Sensor accuracy | $\pm$ 5 mmHg |
| Access | -250 to +200 mmHg |
| Return | -50 to +350 mmHg |
| Pre-filter | -150 to +500 mmHg |
| Filtrate | -250 to +400 mmHg |
| Degassing unit | |
| Pressure | -300 to +30 mmHg |
| Gas removal Max. | 10 ml/min |
| Weight and Dimensions | |
| H x W x D | 170 cm x 50 cm x 60 cm |
| Floor space | Approx. 55 cm (W) x 65 cm (D) |
| Weight | Approx. 75 kg |
| Power Requirements | |
| European voltage | 230 V (alternating voltage) $\pm$ 10%, |
| 50 Hz | |
| Power consumption | 500 VA |
| North American voltage | 115 V (alternating voltage) $\pm$ 10%, |
| 60 Hz | |
| North American consumption | 500 VA |
| Monitor / Detection Parameters | |
| Air detector | Ultrasonic measurement |
| Blood leak detector | 2 or 4 ml blood/1l filtrate at |
| HCT 32% | |
| Display monitor | 10.4" TFT color |
Intended use:
The Edwards Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) therapies.
The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.
7
Image /page/7/Picture/1 description: The image shows handwritten text on a white background. The text includes "K070320", "Page 8 of 8", and "1/31/2007". The handwriting is cursive and slightly slanted. The text appears to be part of a document or record.
Testing Summary:
Electrical Safety and Electromagnetic Compatibility:
Testing has been conducted following the IEC 60601 series of standards, which are FDA recognized voluntary consensus standards.
Bench Testing:
Comparative bench testing of the Edwards Aquarius System and Baxter Accura System, using an Edwards Aqualine Sterile Tubing Set K063293, is included. This concludes that the two machines have substantially equivalent performance.
Animal Testing:
No animal testing is included.
There are no patient or patient's blood contacting materials.
Clinical Testing:
No clinical testing is included.
Other Information:
A summary of European surveillance and vigilance activities is included.
Currently approximately 1,500 machines have been placed on the European market and it is estimated these now (2006 figures) perform approximately 64,000 treatments per year (based on sales of tubing sets).
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|-----------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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Status Controllers of Children
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| www.go.government.com/shoulers | A PROPERTY COLLECTION OF THE | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
A A A C C Status Concess of | MARK AND ANNAL BARREN BARREN BALLERY
Parcellers of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of | | Controllation Company of |
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|---|
Robert Madjno Director of Regulatory and Quality Affairs Edwards Lifesciences Services GmbH
8
Image /page/8/Picture/1 description: The image is a seal for the Department of Health & Human Services (USA). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Edwards Lifesciences Services GmbH c/o Neil R. Armstrong Regulatory Affairs Advisor MeddiQuest Limited Business and Technology Centre Bessemer Drive Stevenage SG1 2DX UNITED KINGDOM
JUN - 7 2007
Re: K070320
Trade/Device Name: Edwards Aquarius System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: May 14, 2007 Received: May 21, 2007
Dear Mr. Armstrong:
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 (Premarket Approval), 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.
Image /page/8/Picture/10 description: The image shows a circular logo with the text "1906-2006 FDA Centennial" in the center. The letters "FDA" are prominently displayed in a bold, stylized font. Three stars are arranged below the word "Centennial". The text around the circle reads "U.S. Department of Health and Human Services".
Protecting and Promoting Public Health
9
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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.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
10
Indications for Use
4070320 510(k) Number (if known):
Edwards Aquarius System Device Name:
Indications for Use:
The Edwards Aquarius System is indicated for continuous solute and/or fluid removal in patients with acute renal failure or fluid overload. The Edwards Aquarius system may also be used in Therapeutic Plasma Exchange (TPE) therapies.
The Edwards Aquarius system is indicated for use in a clinical setting and not for home use.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Posted November 13, 2003)
Page 1 of 1
Nancy Brogdon
Division of Repr ductive, J and Radiological Devi
Radiological Devices
510(k) Number K070320
Indications for Use Statement 4
Page 4.2