(265 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on automated chemical and optical measurements.
No.
The device is described as an in vitro diagnostic device used to automate urine chemistry analysis, aiding in the diagnosis of various conditions, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic device" and that its measurements "aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function."
No
The device description clearly states it is a "fully automated, computer-controlled urine chemistry analyzer" and mentions hardware components like an "electronic refractometer assembly" and "optical absorbance and scattering methods." This indicates it is a hardware device with integrated software, not a software-only device.
Yes, the iChem®VELOCITY™ automated urine chemistry system is explicitly stated to be an in vitro diagnostic (IVD) device in the provided text.
Here are the key phrases that confirm this:
- "The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device..." (in the Intended Use section)
- "Tests performed using the iChem VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only." (in the Intended Use section)
- "The iChem®VELOCITY™ CalChek Kit is a set of assayed and unassayed in vitro diagnostic controls..." (in the Intended Use section, referring to a related product for the system)
N/A
Intended Use / Indications for Use
The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem®VELOCITY™ Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL ™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.
These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
The iChem®VELOCITY™ CalChek Kit is a set of assayed and unassayed in vitro diagnostic controls for monitoring performance of the iChem VELOCITY urine chemistry analyzer.
The controls include assayed liquid controls for the monitoring of the specific gravity measurement module, and unassayed liquid color and clarity controls for the monitoring of color and clarity measurements. The kit also includes a set of assayed reflectance strips for the monitoring of reflectance measurements.
These measurements monitored by these controls are part of an automated urine chemistry analyzer used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.
Product codes (comma separated list FDA assigned to the subject device)
JIL, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JIO, JRE, JMA, KQO
Device Description
The proposed device is a fully automated, computer-controlled urine chemistry analyzer intended for use only with iChemVelocity Chemistry Strips for the measurement of ten urine chemistry analytes from the chemistry strip plus the measurement of specific gravity using an electronic refractometer assembly and the qualitative measurement of color and clarity by optical absorbance and scattering methods, respectively.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS image sensor captures a color image of each of the test pads.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratory use
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)
Not Found
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.
Not Found
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.
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
§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
510(k) Summary
10 852
MAR 2 3 2011
Applicant: Iris Diagnostics, a Division of IRIS International Inc 9172 Eton Avenue Chatsworth, CA 91311 (818) 709-1244 David W. Gates, Ph.D. VP Quality Assurance and Regulatory Affairs
I. iChem VELOCITY Automated Urine Chemistry System
Proprietary and Established Names:
Proprietary names: iChem® VELOCITY™ Automated Urine Chemistry System and iChem VELOCITY™ Chemistry Strips.
Common names: Automated Urinalysis System, Urinary Test System (non-quantitative).
| Regulation Section: | Code | Test |
|---|---|---|
| 21 CFR § 862.2900 | KQO | Automated Urinalysis System |
| 21 CFR § 862.1340 | JIL | Urinary Glucose (Non Quantitative) Test System |
| 21 CFR § 864.6550 | JIO | Occult Blood test |
| 21 CFR § 862.1785 | CDM | Urinary Urobilinogen (Non-Quantitative) |
| 21 CFR § 862.1550 | CEN | Urinary pH (Non-Quantitative) Test System |
| 21 CFR § 862.1510 | JMT | Nitrite (Non-Quantitative) Test System |
| 21 CFR § 862.2800 | JRE | Refractometer for Clinical Use |
| 21 CFR § 864.7675 | LJX | Leukocyte Peroxidase Test |
| 21 CFR § 862.1095 | JMA | Ascorbic Acid Test System |
| 21 CFR § 862.1435 | JIN | Ketones (Non-Quantitative) Test System |
| 21 CFR § 862.1645 | JIR | Urinary Protein or Albumin (Non-Quant.) Test System |
| 21 CFR § 862.1115 | JJB | Urinary Bilirubin and its conjugates (Non-Quantitative) |
| Test System |
Classification names: Automated Urinalysis System; Urinary Test Systems (Non Quantitative); Refractometer for Clinical Use
Class II: Urinary Glucose and Occult Blood
Class I: Automated Urinalysis System, Urinary Urobilinogen, Urinary pH, Ketones, Urinary Protein, Urinary Bilirubin, Nitrite, Leukocyte Peroxidase, Ascorbic Acid, Refractometer.
Indication For Use:
The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem®VELOCITY™ Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL ™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for glucose, blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid, and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not
1
intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.
These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
Devices to which substantial equivalence is claimed
iChem 100 Urine Chemistry Analyzer and iChem 10SG strips
Description of the proposed device:
The proposed device is a fully automated, computer-controlled urine chemistry analyzer intended for use only with iChemVelocity Chemistry Strips for the measurement of ten urine chemistry analytes from the chemistry strip plus the measurement of specific gravity using an electronic refractometer assembly and the qualitative measurement of color and clarity by optical absorbance and scattering methods, respectively.
2
| Device | Proposed
iChem VELOCITY,
iChem VELOCITY strips | Predicate
iChem 100 Analyzer
10SG strips |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The iChem®VELOCITY™
automated urine chemistry
system is an in vitro diagnostic
device used to automate the
urine chemistry analysis profile
using iChem®VELOCITY™
Urine Chemistry Strips. The
iChem VELOCITY can be
used as a stand alone-system,
as well as in an iQ®200 Series
system, a configuration given
the proprietary name
iRICELL™ as it is designed to
be hardware and software
compatible with iQ200 Series
systems. It produces
quantitative results for specific
gravity, semi-quantitative
results for glucose, blood,
leukocyte esterase, bilirubin,
urobilinogen, pH, protein,
ketones and ascorbic acid;
and qualitative results for
nitrites, color and clarity.
iChemVELOCITY strips are
intended for use only with the
iChemVELOCITY analyzer. In
particular they are not
intended for visual reading.
The iChem VELOCITY test
strips are not intended for
visual reading. The
iChemVELOCITY is not
intended to be used as a Point
of Care (POC) analyzer.
These measurements are
used to aid in the diagnosis of
metabolic disorders, kidney
function anomalies, urinary
tract infections, and liver
function. Tests performed
using the iChem VELOCITY
are intended for clinical
laboratory use and in vitro
diagnostic use only. | The iChem100 is a semi-
automated urine analyzer
intended for the in vitro
measurement of the following
analytes: glucose (GLU),
protein (PRO), bilirubin (BIL),
urobilinogen (URO), pH, blood
(BLD), ketones (KET), nitrite
(NIT), leukocytes (LEU),
specific gravity (SG) and color. |
| | 1. Uses similar well-proven
design methods as predicate. | 1. Uses well-proven chemistry
strip methods, and optical
absorbance and scattering for
determination of analytes in
and physical properties of
urine. |
| | 2. Same as predicate | 2. Is capable of stand-alone,
as well as joint operation with
an Iris iQ200 Series System. |
| | 3. Same as predicate | 3. Tests for the concentration
of ascorbic acid in urine. |
| | 4. Same as predicate | 4. Uses fixed-time end-point
reflectance for all chemistry
determinations. |
| Design | 5. Same as predicate | 5. LED's with three different
wavelengths are used to
illuminate the test strips for
measurement. It utilizes a
(CMOS) image sensor that
captures a color image of each
of the test pads. The CMOS
image sensor is able to
photograph almost the whole
length (100mm) of the urine
test strip and all of its width. |
| | 6. Urine color is measured by
the absorbance of white light
through a flowcell containing
urine. Intensities of RGB
wavelengths are measured
with a solid-state
photodetector array. | 6. Urine color is measured
from the color compensation .
pad on the iChem 10 SG strip |
| | 7. Specific gravity is measured
by determining the refractive
index of the specimen. | 7. Specific Gravity is
measured using a test pad
that contains a detergent and
Bromthymol blue that indicates
the presence of ionic
constituents in the urine by
changing color from green to
yellow. The test pad for
specific gravity is impregnated
with a reddish dye so that the
color produced is
yellow-brown tan. |
| Materials | D.C. by an internal switching mode power supply | VD.C. by an external power converter. |
| | Materials are generally same as predicate | Commodity materials and purchased components used in most bench top laboratory instruments, i.e. aluminum frames, thermoplastic enclosures and various molded parts; switching mode power supplies, solder-plated printed circuit board assemblies, programmable and general purpose microprocessors, discrete wire harnesses, flat flexible cables etc. |
| Safety | The proposed device has been certified to comply with latest applicable safety standards for U.S., Canada, and the European Union, including CB Scheme Certificate and Report.
Specifically, these include UL61010-1, CAN/CSA C22.2 #61010-1, IEC 61010-1, CENELEC EN61010-1, IEC61010-2-101, and CENELEC EN 61010-2-81 | The predicate device was tested to U.S. (U.L.) Part 1: General Requirements, UL61010A-1, First Edition. and to the Canadian Standards for Safety Requirements for Electrical Equipment for Measurement, Control and Laboratory Use; Part 1: General Requirements, CAN/CSA-C22.2 No. 1010.1-92, First Edition.
It was also tested to the European/International versions of those norms IEC 61010-1/ EN 61010-1: 2001 "Safety requirements for electrical equipment for measurement, control, and laboratory use: Part I General requirements" |
| Electromagnetic
Compatibility | The proposed device has been tested and certified to CENELEC EN 61326-1 EMC requirements-general and CENELEC EN 61326-2-6 EMC requirements-particular requirements for IVD medical equipment. | Was tested and certified to IEC61326-1:1997+A1 1998+A2:2001 |
| Chemistry strips | 1. The iChem VELOCITY is intended for use only with Iris VELOCITY chemistry strips
2. Analyte detection chemistry composition very similar | 1. The iChem100 is intended for use only with the iChem 10 SG multi-parameter test strips.
2. Analyte detection pads for glucose and pH are more hydrophobic. |
(
3
.
4
·
5
ll. iChem VELOCITY CalChek Kit
Proprietary and Established Names:
Proprietary name: iChem VELOCITY CalChek Kit
Classification name: Quality control material (assayed and unassayed).
Common name: Urinalysis controls
| Regulation Section: | Code | Test |
|---|---|---|
| 21 CFR § 862.1660 | JJX | Single (Specified) Analyte Controls (Assayed And |
| Unassayed) |
Class I: Single (Specified) Analyte Controls, Assayed.
Unclassified: Urinary Color, Urinary Clarity (Turbidity)
Device to which substantial equivalence is claimed
IRISpec Gravity Control 1 ™ and IRISpec Gravity Control 2™ File No. K960054
Arkray Check Strips K013783
Description of the proposed device:
iChem VELOCITY CalChek Reagents are a set of buffer-based solutions intended for the in vitro monitoring of specific gravity, color and clarity.
Intended Use:
The iChem®VELOCITY™ CalChek Kit is a set of assayed and unassayed in vitro diagnostic controls for monitoring performance of the iChem VELOCITY urine chemistry analyzer.
The controls include assayed liguid controls for the monitoring of the specific gravity measurement module, and unassayed liquid color and clarity controls for the monitoring of color and clarity measurements. The kit also includes a set of assayed reflectance strips for the monitoring of reflectance measurements.
These measurements monitored by these controls are part of an automated urine chemistry analyzer used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.
Comparison of the proposed device with the predicate device
| Comparison | iChem VELOCITY Specific
Gravity Calcheks
(Proposed Device) | IRISpec Gravity Control 1™
IRISpec Gravity Control 2™
(Predicate Devices) |
|-------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Composition | Glycerol, salts, food dyes,
preservative, dissolved in deionized
water. No biological material. | Salts, food
coloring,glycerin,stabilizers,
preservative in deionized water |
| Form | Same as predicate | Liquid, ready to use |
6
| Preservatives | Yes | Yes |
|---|---|---|
| Storage | 20-28°C (68-82°F) | Dark, dry place (2-8C) |
| Stability-closed vial | 1 year | 1 year |
| Stability-open vial | Single use | 30 days |
| S.G. Cal value -low | 1.002 ± 0.002 | NA |
| S.G. Cal value-med | 1.030 ± 0.002 | 1.025 ± 0.001 |
| S.G. Cal value-high | 1.060 ± 0.002 | 1.060 ± 0.001 |
| Intended use | Assayed QC materials for | |
| monitoring of urine chemistry | ||
| specific gravity on the iChem | ||
| VELOCITY Urine Analyzer. | For IVD use in the operation of | |
| IRIS Urinalysis workstations | ||
| Analytes | SG at three levels | Specific Gravity at two levels |
| Usage | Vial is intended for one time use | Contents dispensed for multiple |
| uses | ||
| Packaging-container | 10 mL Vacutainers | 500 ml. glass container |
| Comparison | IRIS Reflectance Calchecks
(Proposed Device) | Arkray Check Strips
(Predicate Devices) |
|----------------------------------|------------------------------------------------------------------|-------------------------------------------------------------|
| | | |
| Composition | Munsell paper of various
reflectances laminated to mylar foil | One plain mylar foil, one
laminate |
| No. sets per package | Same as predicate | 2 |
| Reflectance acceptance
ranges | Same as predicate | Programmed into instrument |
| Packaging | Same as predicate | Clear polystyrene cylindrical
tube with press-on stopper |
| No. of strips/set | 5 | 2 |
| Distinct reflectance values | 89.8%,72.3%,39.4%, 19.4%,5.8%, | White (90-110%), gray (~30-40) |
| Measurement wavelengths | 472,525,630nm | 430,500,565,635,760 nm |
| Reusable | No | Yes, until results are out of
range |
| Shelf-life | 1 year | Not specified |
| Storage temperature | 18-25°C | 20-28° C |
| Package Insert | P/N 300-1226 | No |
:
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7
Image /page/7/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or bird in flight. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
HAR 2 3 2011
IRIS International Inc. c/o Mr. David Gates 9172 Eton Avenue Chatsworth, CA 91311
Re: K101852
Trade Name: iChem® VELOCITY™ Automated Urine Chemistry System iChem® VELOCITY™ Chemistry Strips iChem® VELOCITY™ CalChek Kit Regulation Number: 21 CFR §862.1340 Regulation Name: Urinary Glucose (non-quantitative test system) Regulatory Class: Class II Product Codes: JIL, CDM, JJB, JIN, JIR, JMT, LJX, CEN, JIO, JRE, JMA, KQO Dated: March 2, 2011 Received: March 4, 2011
Dear Mr. Gates:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
8
Page 2 –
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
9
Indication for Use
510(k) Number (if known): K101852
Device Names:
iChem® VELOCITY TM Urine Chemistry System
Indication For Use: The iChem®VELOCITY™ automated urine chemistry system is an in vitro diagnostic device used to automate the urine chemistry analysis profile using iChem®VELOCITY™ Urine Chemistry Strips. The iChem VELOCITY can be used as a stand alone-system, as well as in an iQ®200 Series system, a configuration given the proprietary name iRICELL ™ as it is designed to be hardware and software compatible with iQ200 Series systems. It produces quantitative results for specific gravity, semi-quantitative results for qlucose. blood, leukocyte esterase, bilirubin, urobilinogen, pH, protein, ketones and ascorbic acid; and qualitative results for nitrites, color and clarity. iChemVELOCITY strips are intended for use only with the iChemVELOCITY analyzer. In particular they are not intended for visual reading. The iChem VELOCITY test strips are not intended for visual reading. The iChemVELOCITY is not intended to be used as a Point of Care (POC) analyzer.
These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Tests performed using the iChem VELOCITY are intended for clinical laboratory use and in vitro diagnostic use only.
X Prescription Use __ (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K10/852
11 - 10 - 12 - 11 -
10
Indications for Use
KI01852 510(k) Number (if known):
Device Names:
iChem® VELOCITY ™ CalChek Kit
Indication For Use:
The iChem®VELOCITY™ CalChek Kit is a set of assayed and unassayed in vitro diagnostic controls for monitoring performance of the iChem VELOCITY urine chemistry analyzer.
The controls include assayed liquid controls for the monitoring of the specific gravity measurement module, and unassayed liquid color and clarity controls for the monitoring of color and clarity measurements. The kit also includes a set of assayed reflectance strips for the monitoring of reflectance measurements.
These measurements monitored by these controls are part of an automated urine chemistry analyzer used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k/0/852
・・・・・