(179 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description details a simple LED light comb with basic on/off functionality and a timer. There is no mention of any features or components that would suggest the use of AI or ML.
Yes
The device is indicated to treat a medical condition (Androgenetic Alopecia) and promote hair growth, which are therapeutic claims.
No.
The device is indicated to treat Androgenetic Alopecia and promote hair growth, not to diagnose a condition.
No
The device description clearly states it is a "comb-shaped device that emits led light" and includes physical components like a main unit, charging dock, power cable, and a built-in rechargeable battery. This indicates it is a hardware device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Hair Growth Comb is a device that applies light therapy directly to the scalp to promote hair growth. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for treating Androgenetic Alopecia and promoting hair growth, which is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical design and how it delivers light to the scalp. There is no mention of sample collection or analysis.
Therefore, based on the provided information, the Hair Growth Comb is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Hair Growth Comb (Model: SZ-23, SZ-23A) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, Il-1, Il-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
Product codes (comma separated list FDA assigned to the subject device)
OAP
Device Description
The Hair Growth Comb is (Model: SZ-23, SZ-23A) a comb-shaped device that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 650nm (±10nm) while the comb teeth simultaneously part the user's hair to ensure the light reaches the user's scalp. The device is designed as a handheld product, and it consists of the main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter 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)
Non-Clinical Tests Performed:
- Electrical safety, and electromagnetic compatibility: Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility: ANSI/AAMI ES60601-1: 2005 & A1:2012 & A2:2021, IEC 60601-1-11: 2015+AMD1:2020, IEC 60601-2-57: 2023, IEC 60601-1-2: 2014+AMD1:2020, IEC 62471: 2006, IEC 62133-2: 2017+AMD1:2021, IEC 60601-1-6: 2010+AMD1:2013+AMD2:2020, IEC 62366-1: 2015+AMD1:2020.
- Biocompatibility: Tested for Cytotoxicity (ISO 10993-5) and Sensitization (ISO 10993-10). The Hair Growth Comb (Model: SA-23, SA-23A) is biocompatible for its intended use.
- Software verification and validation testing: Conducted and documentation provided as recommended by IEC 62304 and FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff". The level of the documentation of the software was considered as a "basic" level.
Clinical Performance: Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
Key Results: The proposed device uses technology that is similar to the predicate device. The technology and design do not raise new types of questions regarding safety and effectiveness for the proposed indications for use and the performance testing supports that the device can be used safely and effectively for the proposed indications for use. The proposed device is considered to be substantially equivalent to the predicate device K230579, K211038 and K222477.
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.
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
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
0
November 8, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym and the words "U.S. FOOD & DRUG ADMINISTRATION" are in blue. The logo is simple and professional, reflecting the agency's role in protecting public health.
Shenzhen Nuon Medical Equipment Co., Ltd Alain Dijkstra Regulatory Affairs Engineer 1F-3F, No.27-2, Xintang Rd, Xintian Comm, Fuhai Str, Baoan Dist Shenzhen, GuangDong 518000 China
Re: K241342
Trade/Device Name: Hair Growth Comb (SZ-23,SZ-23A) Regulation Number: 21 CFR 890.5500 Regulation Name: Infrared Lamp Regulatory Class: Class II Product Code: OAP Dated: September 26, 2024 Received: September 26, 2024
Dear Alain Dijkstra:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Digitally signed by Yan Fu -S
Yan Fu -S Date: 2024.11.08 13:45:57
-05'00'
for Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Hair Growth Comb (SZ-23,SZ-23A)
Indications for Use (Describe)
The Hair Growth Comb (Model: SZ-23 ,SZ-23A,) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, Il-1, Il-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
510(k) number: K241342
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor Name: Shenzhen Nuon Medical Equipment Co., Ltd Establishment Registration Number: 3030541658 Address: 1st Floor-3rd Floor, No. 27-2, Xintang Road, Xintian Community, Fuhai Street, Baoan District, Shenzhen, Guangdong, China
Contact Person (including title): Alain Dijkstra (CEO) Tel: +86-755-82129361 Fax: +86-755-25024651 E-mail: alaindijkstra@nuonmedical.com
2. Subject Device Information
Trade Name: Hair Growth Comb Model:SZ-23, SZ-23A Classification Name: Laser, Comb, Hair (OAP) Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II
3. Predicate Device Information
3.1 Predicate Device 1 (K230579)
Sponsor: Light Tree Ventures Europe B.V. Trade Name: Aduro Comb Classification Name: Laser, Comb, Hair 510(k) Number: K230579 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II
3.2 Predicate Device (K211038)
Sponsor: Biophotas Inc Trade Name: Biophotas Celluma RESTORE Classification Name: Laser, Comb, Hair 510(k) Number: K211038 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II
5
3.3 Predicate Device 3 (K222477)
Sponsor: Dongguan Lescolton Medical Equipment Co., Ltd Trade Name: Hair Growth Device Classification Name: Laser, Comb, Hair 510(k) Number: K222477 Review Panel: General & Plastic Surgery Product Code: OAP Regulation Number: 21 CFR 890.5500 Regulation Class: II
4. Device Description
The Hair Growth Comb is (Model: SZ-23, SZ-23A) a comb-shaped device that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 650nm (±10nm) while the comb teeth simultaneously part the user's hair to ensure the light reaches the user's scalp. The device is designed as a handheld product, and it consists of the main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.
5. Intended Use / Indications for Use
The Hair Growth Comb (Model: SZ-23, SZ-23A) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
6. Comparison to Predicate Device
Compared with the predicate device, the subject device has similar in the design principle, the intended use, the indications for use, functions and applicable standards. The differences between the subject device and the predicate device do not raise any new questions of safety or effectiveness.
| Elements of
Comparison | Subject Device | Predicate Device
1 | Predicate
Device 2 | Reference
Device | Remark |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Company | Shenzhen Nuon
Medical
Equipment Co.,
Ltd | Light Tree
Ventures Europe
B.V. | Biophotas Inc | Dongguan
Lescolton
Medical
Equipment Co.,
Ltd | -- |
| Trade Name | Hair Growth
Comb | Aduro Comb
(Model: SZ-22A) | Biophotas
Celluma
RESTORE | Hair Growth
Device | -- |
| Classification
Name | Laser, Comb,
Hair (OAP) | Laser, Comb, Hair
(OAP) | Laser, Comb,
Hair (OAP) | Laser, Comb,
Hair (OAP) | -- |
| 510(k) Number | Applying | K230579 | K211038 | K222477 | -- |
| Product Code | OAP | OAP | OAP | OAP | SE |
| Intended Use / | The hair growth | The Aduro Comb | The BioPhotas | The Hair Growth | SE |
| Elements of
Comparison | Subject Device | Predicate Device
1 | Predicate
Device 2 | Reference
Device | Remark |
| Indications for
Use | Comb (Model:
SZ-23, SZ-23A)
is indicated to
treat
Androgenetic
Alopecia and
promote hair
growth in males
who have
Norwood-
Hamilton
Classifications of
Ila - V patterns of
hair loss and to
treat
Androgenetic
Alopecia and
promote hair
growth in
females who
have Ludwig-
Savin Scale I-1
to I-4, II-1, II-2 or
frontal patterns
of hair loss; both
with Fitzpatrick
Skin Types I – IV. | (Model: SZ-22A)
is indicated to
treat Androgenetic
Alopecia and
promote hair
growth in males
who have
Norwood-
Hamilton
Classifications of
Ila - V patterns of
hair loss and to
treat Androgenetic
Alopecia and
promote hair
growth in females
who have Ludwig-
Savin Scale I-1 to
1-4, II-1, II-2 or
frontal patterns of
hair loss; both
with Fitzpatrick
Skin Types I - IV. | Celluma
RESTORE is
indicated to treat
Androgenetic
Alopecia and
promote hair
growth in males
who have
Norwood-
Hamilton
Classifications
of lla - V
patterns of hair
loss and to treat
Androgenetic
Alopecia and
promote hair
growth in
females who
have Ludwig-
Savin Scale I-1
to 1-4, II-1, II-2
or frontal
patterns of hair
loss; both with
Fitzpatrick Skin
Types I - IV. | Device is
indicated to
promote hair
growth in males
with
androgenetic
alopecia who
have Hamilton-
Norwood
Classifications of
Ila-V and
females with
androgenetic
alopecia who
have Ludwig-
Savin
Classifications of
I-II and
Fitzpatrick
Classification of
Skin Phototypes
I to IV. All users
should have
Fitzpatrick Skin
Types I to IV. | |
| Wavelengths | 650±10nm | 650±10nm | 640nm (±25nm) | 650-660nm | SE |
| Treatment time | Each Treatment:
30 min
Total Treatment:
every other day,
for 16 weeks | Each Treatment:
30 min
Total Treatment:
every other day,
for 16 weeks | Each
Treatment:30
min Total
Treatment:
every other day,
for 16 weeks | LS-D620: 20
minutes each
time for 16
weeks
LS-D630: 12
minutes each
time for 16
weeks | SE |
| Treatment area | 31.5 cm² | 31.5 cm² | 475 cm² | No publicly
available | SE |
| Energy density
(mw/cm²) | SZ-23: 2.77
mw/cm²
SZ-23A:
5.54mw/cm² | 2.77 mw/cm² | 2.77 mw/ cm² | 40mW/cm² | SE
NOTE 1 |
| Elements of
Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Reference Device | Remark |
| Treatment
Dose(J/cm²) | SZ-23: 4.98 J/
cm²
SZ-23A: 9.96 J/
cm2 | 4.98 J/ cm² | 4.98 J/ cm² | No publicly
available | SE
NOTE 2 |
| Energy Source | Light emitting
diodes | Light emitting
diodes | Light emitting
diodes | Low-level laser
diodes | SE |
| Number of
LEDs | SZ-23: 22 LEDs
SZ-23A: 11 LEDs | 22 LEDs | No publicly
available | LS-D620 Laser
diodes: 80
LS-D630 Laser
diodes: 162 | SE |
| Power supply | Input: DC 5 V, 2
A
Battery: DC 3.7
V, 600 mAh, 2.22
Wh | Input: 100-240V~,
50/60Hz,
0.35Amax
Output:5V, 2A
Battery: DC 3.7 V,
600 mAh, 2.22
Wh | 110-120V | No publicly
available | SE |
| Location for
Use | OTC | OTC | OTC | OTC | SE |
| Safety and
EMC | IEC 60601-1
IEC 60601-1-11
IEC 62471
IEC 60601-2-57
IEC 60601-1-2
IEC 62133-2 | IEC 60601-1
IEC 60601-1-11
IEC 62471
IEC 60601-2-57
IEC 60601-1-2
IEC 62133-2 | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-11
IEC 60601-2-57
IEC 60601-1-2
IEC 60825-1 | SE |
| Biocompatibility | All patient
contacting
materials comply
with ISO 10993-
5, ISO 10993-10 | All patient
contacting
materials comply
with ISO 10993-5,
ISO 10993-10 | All patient
contacting
materials
comply with ISO
10993-5, ISO
10993-10 | All patient
contacting
materials comply
with ISO 10993-
1, ISO 10993-5,
ISO 10993-10 | SE |
6
7
7. Test Summary
7.1 Non-Clinical Tests Performed
1) Electrical safety, and electromagnetic compatibility
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- ANSI/AAMI ES60601-1: 2005 & A1:2012 & A2:2021 Medical electrical equipment Part 1: General req . uirements for basic safety and essential performance. / IEC 60601-1:2005+AMD1:2012+AMD2:2020 E dition 3.2
8
- � IEC 60601-1-11: 2015+AMD1:2020 Edition 2.1 Medical Electrical Equipment --Part 1: General Require ments for Basic Safety and Essential Performance --Collateral Standard: Requirements for Medical Ele ctrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment.
- � IEC 60601-2-57: 2023 Edition 2.0 Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeuti c, diagnostic, monitoring and cosmetic/aesthetic use.
- � IEC 60601-1-2: 2014+AMD1:2020 Edition 4.1 Medical electrical equipment - Part 1-2: General require ments for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
- ◆ IEC 62471: 2006 First edition Photobiological safety of lamps and lamp systems.
- � IEC 62133-2: 2017+AMD1:2021 Edition1.0 Secondary cells and batteries containing alkaline or other n on-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
- � IEC 60601-1-6: 2010+AMD1:2013+AMD2:2020 Edition 3.2 Medical electrical equipment - Part 1-6: Ge neral requirements for basic safety and essential performance - Collateral standard: Usability
- � IEC 62366-1: 2015+AMD1:2020 Edition 1.1 Medical devices - Part 1: Application of usability engineeri ng to medical devices
2) Biocompatibility
There is one patient directly contracting materials in the subject device as the following list.
| Component of | Material of | Body Contact Category
(ISO 10993-1) | Contact Duration (ISO
10993-1) |
|------------------|-------------|----------------------------------------|-----------------------------------|
| Device Requiring | Component | | |
| Shell | PC+ABS | Surface-skin | Less than 24 hours |
The Nature of body contact is surface, skin contact. And the contact duration is less than 24 hours. According to "Table A.1 - Initial evaluation tests for consideration" in ISO 10993-1, the applicable biological effect is:
- Cytotoxicity (ISO 10993-5) �
- Sensitization (ISO 10993-10) �
- � Irritation or intracutaneous reactivity (ISO 10993-10)
Hair Growth Comb (Model: SA-23, SA-23A) is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization). So, ISO 10993-5 and ISO 10993-10 test reports have been provided.
9
3) Software verification and validation testing
Software verification and validation testing were conducted and documentation was provided as recommended by the IEC 62304 and FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions - Guidance for Industry and Food and Drug Administration Staff" The level of the documentation of the software for was considered as a "basic" level, since a failure or a latent design flaw could directly lead to a minor Injury to the patient or operator.
7.2 Summary of Clinical Performance
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
8.Conclusion:
The proposed device uses technology that is similar to the predicate device. The technology and design do not raise new types of questions regarding safety and effectiveness for the proposed indications for use and the performance testing supports that the device can be used safely and effectively for the proposed indications for use. The proposed device is considered to be substantially equivalent to the predicate device K230579, K211038 and K222477.
Summary Prepared Date:2024-11-7
Version: V5.0