(281 days)
Not Found
No
The summary describes a standard radiofrequency diathermy device with manual parameter control and basic user interface functions. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, control, or optimization.
Yes
The device's intended use clearly states it is for "treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation" and "temporary reduction in the appearance of cellulite," which are therapeutic applications.
No.
The device's intended use is to provide topical heating for therapeutic purposes (relief of pain, muscle spasms, increased local circulation) and to reduce the appearance of cellulite. It does not describe any function related to diagnosing medical conditions.
No
The device description clearly outlines physical hardware components such as electrodes, plates, a keyboard, light columns, a screen, and mentions electrical safety and electromagnetic compatibility testing, indicating it is a hardware device with integrated software for control and 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 states that the device is for "topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions" and "to provide a temporary reduction in the appearance of cellulite." These are therapeutic applications, not diagnostic ones.
- Device Description: The description details a device that applies radio frequency electrical currents to the patient's body for heating purposes. This is consistent with a therapeutic device, not a device that analyzes samples from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, the CAPENERGY C Devices are therapeutic devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The CAPENERGY C Devices - C100, C200, C300, C400, C50 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.
The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
Product codes
PBX
Device Description
The proposed device is an equipment for diathermy by energy transfer using radio frequency alternating electrical currents applied to the patient by using electrodes or plates.
The RF current is coupled to the human body by means of an insulated or non-insulated electrode -the active accessory-, which together with the body and the return electrode -the passive plate- forms an electric circuit, which allows the passage of RF current through the body areas situated between the two electrodes.
The number of available channels on the different models of the CAPENERGY product range varies from one to four. When a model has several channels, these operate independently. Each channel has a keyboard that lets you manage the parameters of frequency and channel power. It also has two light columns that report the selected power level and a qualitative indication of the power delivered by the channel.
The user interface has a screen and a keyboard that allows you to manage several functions: timer, connected accessories management, state management, energy and temperature measurements and alarms. The user interface is organized in a menu system that makes it possible to choose between the different features available on the equipment.
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)
The proposed device has been subject to bench testing to determine to performance specifications and requirements taking account of its intended use as diathermia radiofrequency device. Based on the bench tests conducted, the device demonstrated ability to reach and maintain therapeutic temperature (40-45°C) on the surface of human skin for at least 10 minutes.
Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:
- Electrical safety
- Electromagnetic compatibility
In addition to the electrical safety testing performed, software verification was conducted to IEC 62304: 2006 - Medical device software - Software Life-Cycle Processes, and FDA guidance on software validation. The results of this testing conclude the software has met these requirements.
Patient contacting materials have been evaluated according to the requirements of ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing, and confirmed to be biocompatible for their intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
February 11, 2020
Capenergy Medical S.L. Pilar Sanchez General Manager Avinguda Mare de Deu de Montserrat, 41 Sant Joan Despi, Barcelona, Spain 08970
Re: K191202
Trade/Device Name: Capenergy - C100, C200, C300, C400, C50 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: October 31, 2019 Received: November 14, 2019
Dear Pilar Sanchez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
CAPENERGY C Devices - C100, C200, C300, C400, C50
Indications for Use (Describe)
The CAPENERGY C Devices - C100, C200, C300, C50 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.
The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information, Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
3
Image /page/3/Picture/2 description: The image features the logo for Capenergy. The logo consists of the word "CAPENERGY" in a bold, light blue sans-serif font. Above the text is an abstract graphic that includes a solid orange circle, which is partially obscured by a light blue abstract shape that resembles a stylized depiction of a ship or energy wave. The background is white, and a thin gray line is present at the bottom of the image.
Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50
SECTION 05 - 510(k) Summary
- 510 (k) Submitter: Capenergy Medical S.L. Pol. Ind. Fontsanta Av. Mare de Deu de Montserrat, 41 bis Pje 1º derecha 08970 Sant Joan Despí Barcelona - España
Establishment Registration Number: Not Established
| Contact person: | Pilar Sánchez
General Manager |
|-----------------|----------------------------------|
| Phone: | +34 93 477 43 48 |
| e-mail: | pilar@capenergy.com |
| DATE OF SUBMISSION: | 2020-02-10 |
|---|---|
| SUBMITTER NAME: | Capenergy Medical S.L. |
| SUBMITTER ADDRESS: | Av. Mare de Deu de Montserrat, 41 bis Pje 1º derecha |
| 08970 Sant Joan Despí | |
| Barcelona - España |
| CONTACT: | Pilar Sánchez |
|---|---|
| TELEPHONE: | +34 93 477 43 48 |
e-mail:
DEVICE TRADE NAME: CAPENERGY - C 100, C 200, C 300, C 400, C 50 COMMON NAME: Massager, Vacuum, Radio Frequency Induced Heat CLASSIFICATION NAME: Massager, Vacuum, Radio Frequency Induced Heat REGULATION NUMBER: 21 CFR 878.4400 PRODUCT CODE: PBX Indiba Diathermia Radiofrequency Device - K161458 PREDICATE DEVICE(S): Winback Back 3SE - K162828
DEVICE DESCRIPTION:
The proposed device is an equipment for diathermy by energy transfer using radio frequency alternating electrical currents applied to the patient by using electrodes or plates.
4
510(k) Premarket Notification
Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50
SECTION 05 - 510(k) Summary
The RF current is coupled to the human body by means of an insulated or non-insulated electrode -the active accessory-, which together with the body and the return electrode -the passive plate- forms an electric circuit, which allows the passage of RF current through the body areas situated between the two electrodes.
The number of available channels on the different models of the CAPENERGY product range varies from one to four. When a model has several channels, these operate independently. Each channel has a keyboard that lets you manage the parameters of frequency and channel power. It also has two light columns that report the selected power level and a qualitative indication of the power delivered by the channel.
The user interface has a screen and a keyboard that allows you to manage several functions: timer, connected accessories management, state management, energy and temperature measurements and alarms. The user interface is organized in a menu system that makes it possible to choose between the different features available on the equipment.
SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
In the establishment of substantial equivalence, the CAPENERGY devices is compared with the following previously cleared devices:
Comparison of the proposed devices with the predicate devices is summarized in the following table:
| ELEMENT OF
COMPARISON | Primary Predicate
Indiba Diathermia
Radiofrequency Device
(Indiba USA Inc.) | Reference predicate
device
Winback Back 3SE
(Winback USA Corp) | Subject Device
CAPENERGY - C100, C200, C300,
C400, C50
(Capenergy Medical S.L) |
|--------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| REGULATORY DATA | | | |
| Regulatory Class | Class II | Class II | Class II |
| Classification name | Electrosurgical, cutting and
coagulation and accessories | Electrosurgical, cutting
and coagulation and
accessories | Electrosurgical, cutting and
coagulation and accessories |
| Regulation number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21CFR 878.4400 |
| Product code | PBX | PBX | PBX |
| FDA clearance | 510(k) Cleared: K161458 | 510(k) Cleared:
K162828 | - |
| USE | | | |
5
Image /page/5/Picture/2 description: The image contains the logo for CAPENERGY. The logo features the word "CAPENERGY" in a bold, blue sans-serif font. Above the text is an abstract graphic consisting of a solid orange circle and a light blue, stylized shape that resembles a lightning bolt or a stylized plant.
Document: CAPENERGY - C 100, C 200, C 300,
C 400, C 50
| ELEMENT OF
COMPARISON | Primary Predicate
Indiba Diathermia
Radiofrequency Device
(Indiba USA Inc.) | Reference predicate
device
Winback Back 3SE
(Winback USA Corp) | Subject Device
CAPENERGY - C100, C200, C300,
C400, C50
(Capenergy Medical S.L) |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use
(from the Instructions for
Use sheet) | The Indiba Diathermia
Radiofrequency Devices are
intended to provide topical
heating for the purpose of
elevating tissue temperature for
treatment of selected medical
conditions such as: relief of
pain, muscle spasms, increase
in local circulation.
The massage device provided
is intended to provide a
temporary reduction in the
appearance of cellulite. | The Winback Back
3SE device is intended
to provide topical
heating for the purpose
of elevating tissue
temperature for
treatment of selected
medical conditions
such as: relief of pain,
muscle spasms,
increase in local
circulation.
The Winback Back
3SE massage device
provided is intended to
provide a temporary
reduction in the
appearance of cellulite. | The CAPENERGY C Devices -
C100, C200, C300, C400, C50,
C500 are intended to provide topical
heating for the purpose of elevating
tissue temperature for treatment of
selected medical conditions such as:
relief of pain, muscle spasms,
increase in local circulation.
The massage device provided is
intended to provide a temporary
reduction in the appearance of
cellulite |
| ELEMENT OF
COMPARISON | Primary Predicate
Indiba Diathermia
Radiofrequency Device
(Indiba USA Inc.) | Reference predicate
device
Winback Back 3SE
(Winback USA Corp) | Subject Device
CAPENERGY - C100, C200, C300,
C400, C50
(Capenergy Medical S.L) |
| Contraindications
(from the Instructions for
Use sheet) | Pacemakers or other
electronical implants
Pregnancy
Skin disorders (open wounds or
recent burnts)
Thrombophlebitis
External use. Do not use on
endocavity ways (oral, vaginal,
rectal)
Persons suffering from lack of
sensibility (congenital
insensibility to pain, paraplegia
or pharmacological treatments
reducing sensibility to pain and
heat) | The practitioner must
avoid using the
equipment on
patients with:
Pace maker
Insulin pump
Neurostimulators.
Pregnancy
High blood pressure
or hypotension
Cartilage growth
Cancer
Bleeding disorders
Infectious diseases
where heat is
proscribed
Phlebitis
Tuberculosis.
he practitioner must
seek medical advice
on the following:
insensitivity to pain
insensitivity to heat
Burns
Cancerous lesion in
the treatment area. | Presence of pacemakers or other
active implants, as cochlear
implants, insuline pump, etc.
Implanted cables
Angina
Epilepsy
Nervous diseases
Pregnancy
Lactation
Cardiovascular dysfunction
Neoplasm
Insensibility to temperature ,even if
only temporary
Decompensated arteriopathies
Active infectious bacterial
processes
Coagulation problems
Presence of metal implants
(consult with specialist) |
| PRINCIPLE OF
OPERATION | | | |
| Operating principle | Radio frequency diathermy | Radio frequency
diathermy | Radio frequency diathermy |
| TECHNOLOGICAL
CHARACTERISTICS | | | |
| General description | The Indiba Diathermia
Radiofrequency Device is a
therapeutic device for deep,
non-invasive diathermy. The
device consists of a console
which generates a
radiofrequency current which is
delivered to the patient, in
monopolar form, through two
different types of electrodes:
stainless steel conductive | The Winback Back
3SE generates a high
frequency sinusoidal
current with a
monopolar mode of
application using two
electrodes. A fixed
electrode is placed in
contact with the patient
and a handheld
electrode is | The CAPENERGY - C100, C200,
C300, C400, C50 are devices for
diathermy by energy transfer using
radio frequency alternating electrical
currents applied to the patient by
using electrodes or plates.
Its particular emission of
frequencies, the ability to regulate
and control the increase of the
desired temperature allows to
operate with a maximum |
| ELEMENT OF | Primary Predicate
Indiba Diathermia | Reference predicate
device | Subject Device
CAPENERGY - C100, C200, C300, |
| COMPARISON | Radiofrequency Device | Winback Back 3SE | C400, C50 |
| | (Indiba USA Inc.)
resistive electrodes, and thin-
layer insulated capacitive
electrodes. The electrodes are
inserted into a
handle/handpiece, one handle
for each kind of electrode, and
the handle is connected to the
console by means of a 2-metre
cable.
In resistive mode the system
delivers a high-frequency
current of 448 kHz directly to
the patient's skin surface. In
capacitive mode, the electrode
coating creates a layer
between the electrode and the
human tissue, forming a
capacitor that allows a high-
frequency current to pass. | (Winback USA Corp)
manipulated by a
therapist. When both
electrodes are in
contact with a patient
the electrical circuit is
closed and RF therapy
can be provided.
The device can be
operated in a capacitor
resistive monopolar
mode and a multipolar
mode.
The product consists of
a power console on a
moveable trolley, LCD
monitor, and
accessories including
capacitive resistive
electrodes and
multipolar electrodes.
The unit can be
adjusted to provide
various levels of
treatment frequency
ranging from 300 KHz | (Capenergy Medical S.L)
temperature of 45 °C, and never
exceed 47 °C (for safety). |
| RF frequency | Frequency emission is limited
to the following value:
0,40 MHz - 0,449 MHz | to 1 MHz.
300kHz – 1 MHz | Fixed values are established for the
treatment time, percentage of power
output and working frequency. There |
| | | | are three available options:
0,8MHz +/-25%
1,0 MHz +/-25%
1,2 MHz +/-25% |
| Supply voltage and
frequency | (100 – 240) V ~ 50/60 Hz | (100 - 240) V ~ 50/60
Hz | 100-120/200-240V ± 10%, 50/60 Hz |
| Output power | 100-200 W | 300 W | 45 W +/-10% for a charge of 06-j530
ohms to 1 MHz |
| ELEMENT OF
COMPARISON | Primary Predicate
Indiba Diathermia
Radiofrequency Device
(Indiba USA Inc.) | Reference predicate
device
Winback Back 3SE
(Winback USA Corp) | Subject Device
CAPENERGY - C100, C200, C300,
C400, C50
(Capenergy Medical S.L) |
| Dimensions | 400 mm x 530 mm x 150 mm | 1000 x 370 x 450 mm | 562 mm x 211 mm x 420 mm
220 mm x 211 mm x 420 mm |
| Weight | 8,6 kg (CT9); 8,4 kg (CT8) | 18 Kg | 10,7 Kg - 22,5 kg |
| Safety Class /
Protection | Class I - Type BF | Class I - Type BF | Class I - Type BF |
| Waveform | Sinusoidal | Sinusoidal | Sinusoidal |
| Compliance with
voluntary standards /
LAB tests performed | IEC 60601-1:2005
IEC 60601-1-2:2007
IEC 62304:2006
ISO10993-1:2009 | IEC 60601-1:2005
IEC 60601-1-2:2007
ISO10993-1:2009 | IEC 60601-1:2005 + /A1:2012
IEC 60601-1-2:2015
IEC 60601-1-6:2010
IEC 62304:2006
ISO10993-1:2009 |
| Environmental
Conditions (Use) | Temperature: 10° to 40°C
Relative Humidity: 30-75% | Temperature: 15° to 40°C
Relative Humidity: 30-
60% | Temperature: 10° to 40°C (+/- 2°C)
Relative humidity: less than 80%. |
6
Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50
7
Document:
CAPENERGY - C 100, C 200, C 300, C 400, C 50
8
Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50
9
Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50
SECTION 05 - 510(k) Summary
INTENDED USE:
As established in the Indications for Use Statement:
The CAPENERGY C Devices - C100, C200, C300, C400, C50 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation. The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The proposed device has been subject to bench testing to determine to performance specifications and requirements taking account of its intended use as diathermia radiofrequency device. Based on the bench tests conducted, the device demonstrated ability to reach and maintain therapeutic temperature (40-45℃) on the surface of human skin for at least 10 minutes.
Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:
- Electrical safety -
- -Electromagnetic compatibility
In addition to the electrical safety testing performed, software verification was conducted to IEC 62304: 2006 - Medical device software - Software Life-Cycle Processes, and FDA guidance on software validation. The results of this testing conclude the software has met these requirements.
Patient contacting materials have been evaluated according to the requirements of ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing, and confirmed to be biocompatible for their intended use.
SUMMARY DISCUSSION OF CLINICAL DATA:
Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted.
10
Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50
SECTION 05 - 510(k) Summary
CONCLUSIONS:
The subject device CAPENERGY – C 100, C 200, C 300, C 50 – is similar to the predicate devices in principles of operation and technological characteristics. Testing was conducted to evaluate the performance of the subject device and to compare results to the performance of the predicate devices. Results of validation and verification activities in design control that included testing / certification to the designated standards and performance testing of the devices has demonstrated substantial equivalence of the subject device to the predicate in terms of safety and effectiveness for requested intended use.
We conclude that the subject device CAPENERGY - C 100, C 300, C 400, C 50 is substantially equivalent to the predicate devices in terms of safety and effectiveness for the requested intended use.