(149 days)
Not Found
No
The device description details fixed, pre-programmed compression modes and does not mention any adaptive or learning capabilities. The summary of performance studies focuses on standard device testing and software validation for a "moderate" level of concern, which is typical for non-AI/ML devices. There is no mention of AI, ML, or related concepts in the provided text.
Yes
The device is clearly indicated for "Deep Vein Thrombosis Prevention Therapy" and its intended use includes aiding in the prevention and treatment of various conditions, such as DVT, venous stasis ulcers, and reducing edema and pain, which are all therapeutic actions.
No
The device is described as an intermittent pneumatic compression system intended to provide sequential compression therapy to stimulate blood flow and aid in the prevention/treatment of conditions like DVT and ulcers. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it consists of "a pair of pumps and sleeve assemblies," which are hardware components. The summary also mentions hardware-related testing like "Pressure delivery test," "Bust and leak test," and "Electrical Safety and Electromagnetic Compatibility (EMC) tests."
Based on the provided information, the SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- SyneCare 1100 Function: The SyneCare 1100 is a physical therapy device that applies intermittent pneumatic compression to the lower limbs. It works by stimulating blood flow externally, not by analyzing biological samples.
- Intended Use: The intended use clearly states it's for preventing DVT and enhancing blood circulation by stimulating blood flow in the extremities. This is a mechanical action, not a diagnostic test performed on a sample.
Therefore, the SyneCare 1100 falls under the category of a therapeutic or physical medicine device, not an IVD.
N/A
Intended Use / Indications for Use
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:
- Aid in the prevention of DVT;
- Enhance blood circulation:
- Diminish post-operative pain and swelling;
- Reduce wound healing time;
- Aid in the treatment and healing of: stasis dernatits, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.
Product codes
JOW
Device Description
SyneCare 1100 Deep Vein Thrombosis Prevention Thereinafter as SyneCare 1100) is an ambulatory, portable, light weight, prescriptive device intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The SyneCare 1000 system consists of a pair of pumps and sleeve assemblies, in which each sleeve has 2 compression chambers.
The device will alternatively inflate and deflate the sleeve to stimulate blood flow in the extremities (muscle contraction). The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle. There are three default modalities. Mode 1 is inflating chamber 1 up to the preset pressure and then deflating, and then inflating chamber 2 up to the preset pressure and then deflating, and repeat the above process with an interval of 40 seconds. Mode 2 is inflating chamber 1 up to the preset pressure and then inflating chamber 2 up to the preset pressure, then deflating at the same time. The above process is repeated with an interval of 40 seconds. The third mode is inflating chamber 1& 2 simultaneously to the preset pressure (50mmHg) and hold for 9 seconds, then deflating to the preset pressure (40mmHg) at the same time and hold for 10 seconds, and then deflating. The above process is repeated with an interval of 30 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs (Calf)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home and clinical setting, prescribed by a physician.
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 were conducted to verify that the proposed device met all design specifications as same to the predicate device.
Performance tests were conducted: Appearance test, Button function test, Alarm function test, Pressure delivery test, Time parameter test, Battery charging test, Noise test, Bust and leak test.
Biocompatibility testing including Cytotoxicity, Sensitization and Irritation were conducted and the test results showed the material is non-toxic, non-sensitizing and non-irritating.
Electrical Safety and Electromagnetic Compatibility (EMC) tests were conducted according to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-1-11.
Software Verification and Validation: The software was considered as a "moderate" level of concern and had been verified and validated by the manufacturer.
No clinical study is included in this submission.
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
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 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 & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 18, 2021
Jiangsu Synecoun Medical Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai SUNGO Management Consulting Company Limited. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K211937
Trade/Device Name: SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: October 11, 2021 Received: October 14, 2021
Dear Ivy Wang:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 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).
Sincerely,
Nicole Gillette Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211937
Device Name
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System
Indications for Use (Describe)
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:
- · Aid in the prevention of DVT;
- · Enhance blood circulation:
- · Diminish post-operative pain and swelling;
- · Reduce wound healing time;
• Aid in the treatment and healing of: stasis dernatits, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.
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)
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510(K) Summary
Date of summary prepared: 2021-11-17
A. Applicant:
Jiangsu Synecoun Medical Technology Co., Ltd. Address: 1/2F East Side, No. 50, Building G60, East of Lujia Road, West of Koutai Road, China Medical City, Taizhou, Jiangsu, China Contact person: Lei Zhu Tel: +86-523-86511020 Fax: +86-523-86511020
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System Common Name: Compressible Limb Sleeve Device Model: SyneCare 1100
Regulatory Information Classification Name: Compressible limb sleeve Classification: Class II Product code: JOW Regulation Number: 870.5800 Review Panel: Cardiovascular
C. Predicate device:
| 510(k) # | Device name | Manufacturer |
|---|---|---|
| K203310 | SyneCare 1000 Deep Vein Thrombosis Prevention | |
| Therapy System | Jiangsu Synecoun Medical | |
| Technology Co., Ltd. | ||
| K203016 | DVT-2600 | Daesung Maref Co., LTD |
D. Indications for use of the device:
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in
4
patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to:
- Aid in the prevention of DVT;
- Enhance blood circulation;
- Diminish post-operative pain and swelling;
- Reduce wound healing time;
• Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs.
- · As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.
E. Contraindications:
SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System should NOT be used to treat the following conditions:
- Severe arteriosclerosis or other ischemic vascular diseases
- Acute or active deep vein thrombosis
- Existing pulmonary edema, pulmonary embolisms, and/or congestive cardiac failure
- On patients with neuropathy, active infections, and/or thrombophlebitis
- On extremities that are extremely deformed, insensitive to pain, or where increased venous or lymphatic return is undesirable
- Any local skin or tissue condition in which the garments would interfere including but not limited to: o Vein ligation
- o Gangrene
- o Open wounds
- o Recent skin graft
- o Dermatitis
- o Massive edema
ﺖ Device Description:
SyneCare 1100 Deep Vein Thrombosis Prevention Thereinafter as SyneCare 1100) is an ambulatory, portable, light weight, prescriptive device intermittent pneumatic compression system intended to provide sequential compression therapy to a patient's lower limbs. The SyneCare 1000 system consists of a pair of pumps and sleeve assemblies, in which each sleeve has 2 compression chambers.
The device will alternatively inflate and deflate the sleeve to stimulate blood flow in the extremities (muscle contraction). The compression massage direction is from limb end to body center by inflating the air chambers sequentially and then deflating as one cycle. There are three default modalities. Mode 1 is inflating chamber 1 up to the preset pressure and then deflating, and then inflating chamber 2 up to the preset pressure and then deflating, and repeat the above process with an interval of 40 seconds. Mode 2 is inflating chamber 1 up to the preset pressure and then inflating chamber 2 up to the preset pressure, then deflating at the same time. The above process is repeated with an interval of 40 seconds. The third mode is inflating chamber 1& 2 simultaneously to the preset pressure (50mmHg) and hold for 9 seconds, then deflating to the preset pressure (40mmHg) at the same time and hold for 10 seconds, and then deflating. The above process is repeated with an interval of 30 seconds.
5
G. Comparison with predicate device
| Device | Proposed Device | Predicate Device | Reference Device | Result |
|---|---|---|---|---|
| 510K # | K211937 | K203310 | K203016 | - |
| Manufacturer | Jiangsu Synecoun Medical Technology Co., Ltd. | Jiangsu Synecoun Medical Technology Co., Ltd. | Daesung Maref Co., LTD | - |
| Classification | Class II Device, JOW (21 CFR870.5800) | Class II Device, JOW (21 CFR870.5800) | Class II Device, JOW (21 CFR870.5800) | Same |
| Indications for use | SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System is intended to be an easy to use portable system, prescribed by a physician, for use in the home or clinical setting to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used to: | |||
| • Aid in the prevention of DVT; | ||||
| • Enhance blood circulation; | ||||
| • Diminish post-operative pain and swelling; | ||||
| • Reduce wound healing time; | ||||
| • Aid in the treatment and healing of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs. | ||||
| • As a prophylaxis for DVT by persons expecting to be stationary for long periods of time. | SyneCare 1000 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to: | |||
| • Aid in the prevention of DVT; | ||||
| • Enhance blood circulation; | ||||
| • Diminish post-operative pain and swelling; | ||||
| • Reduce wound healing time; | ||||
| • Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs | ||||
| • As a prophylaxis for DVT by persons expecting to be stationary for long periods of time. | A device intended to prevent Deep Vein Thrombosis/Pulmonary Embolism (DVT/PE) by increasing venous blood flow to a patient who has a risk of DVT/PE. | Same | ||
| Prescription Use | Yes | Yes | Yes | Same |
| Contraindications | SyneCare 1100 should NOT be used to treat the following conditions: | |||
| • Severe arteriosclerosis or other | SyneCare 1000 series system should NOT be used to treat the following conditions: | |||
| • Severe arteriosclerosis or other | The DVT-2600 system is not recommended for use with the following conditions: | |||
| -pre-existing deep vein | Same | |||
| ischemic vascular diseases | ||||
| • Acute or active deep vein thrombosis | ||||
| • Existing pulmonary edema, pulmonary | ||||
| embolisms, and/or congestive cardiac | ||||
| failure | ||||
| • On patients with neuropathy, active | ||||
| infections, and/or thrombophlebitis | ||||
| • On extremities that are extremely | ||||
| deformed, insensitive to pain, or | ||||
| where increased venous or lymphatic | ||||
| return is undesirable | ||||
| • Any local skin or tissue condition in | ||||
| which the garments would interfere | ||||
| including but not limited to: | ||||
| o Vein ligation | ||||
| o Gangrene | ||||
| o Open wounds | ||||
| o Recent skin graft | ||||
| o Dermatitis | ||||
| o Massive edema | ischemic vascular diseases | |||
| • Acute or active deep vein thrombosis | ||||
| • Existing pulmonary edema, pulmonary | ||||
| embolisms, and/or congestive cardiac | ||||
| failure | ||||
| • On patients with neuropathy, active | ||||
| infections, and/or thrombophlebitis | ||||
| • On extremities that are extremely | ||||
| deformed, insensitive to pain, or | ||||
| where increased venous or lymphatic | ||||
| return is undesirable | ||||
| • Any local skin or tissue condition in | ||||
| which the garments would interfere | ||||
| including but not limited to: | ||||
| o Vein ligation | ||||
| o Gangrene | ||||
| o Open wounds | ||||
| o Recent skin graft | ||||
| o Dermatitis | ||||
| o Massive edema | thrombosis, phlebothrombosis | |||
| or pulmonary embolism | ||||
| -presumptive evidence of | ||||
| congestive heart failure | ||||
| -inflammatory phlebitis process | ||||
| -severe arteriosclerosis or other | ||||
| ischemic vascular disease | ||||
| -decompensated cardiac | ||||
| insufficiency | ||||
| -carcinoma metastasis in the | ||||
| affected extremity | ||||
| -lymphatic return is undesirable | ||||
| -severe arteriosclerosis or active | ||||
| infection | ||||
| Use settings | Home and clinical | Home and clinical | Professional healthcare | |
| environment | Same | |||
| Application | Non-invasive / external | Non-invasive / external | Non-invasive / external | Same |
| Portability | Portable, ambulant | Portable, ambulant | Portable | Same |
| Basis | ||||
| of | ||||
| operation | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower Limb(s). | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the lower Limb(s). | Aids venous return by using cyclic, intermittent, pneumatic pressure application (inflation followed by deflation) to compress the treated area. | Same |
| Location | ||||
| of | ||||
| treatment | ||||
| application | Lower limb(s) (Calf) | Lower limb(s) (Calf) | Lower limbs (Calf, Thigh, Foot) | Same |
| System | Electronic, microprocessor controlled | Electronic, microprocessor controlled | Electronic, microprocessor | Same |
| management | controlled | |||
| Treatment | ||||
| delivery | Uses electronic microprocessor and | |||
| pneumatics to inflate and deflate bladder cuffs | ||||
| to achieve compression therapy | Uses electronic microprocessor and | |||
| pneumatics to inflate and deflate bladder cuffs | ||||
| to achieve compression therapy | Uses electronic microprocessor | |||
| and pneumatics to inflate and | ||||
| deflate bladder cuffs to achieve | ||||
| compression therapy | Same | |||
| Pressure Source | Micropump controlled by electronic processor | Micropump controlled by electronic processor | Micropump controlled by | |
| electronic processor | Same | |||
| Physical | ||||
| components | Pump and sleeve come assembled | Pump and sleeve come assembled | Controller, air connectable hose, | |
| AC power cord | Same | |||
| Operating | ||||
| Modes | 3 different modes | |||
| Image: Mode 1 | ||||
| Image: Mode 2 | ||||
| Image: Mode 3 | 1 mode | |||
| Image: 1 mode | 2 different modes | |||
| DVT operation mode | ||||
| Image: DVT operation mode | ||||
| Lymph operation mode | ||||
| Image: Lymph operation mode | Different | |||
| Although the | ||||
| operating modes | ||||
| are different, the | ||||
| working pressure | ||||
| range is same, no | ||||
| adverse effect | ||||
| would cause by this | ||||
| difference. | ||||
| Hold time | Mode 1 & 2: 0s | |||
| Mode 3: 9+10s | 0s | 0s | Different | |
| The hold time is | ||||
| different due to the | ||||
| operating modes, | ||||
| while the working | ||||
| pressure range is | ||||
| same, no adverse | ||||
| effect would cause | ||||
| by this difference. | ||||
| This difference will | ||||
| not affect safety. | ||||
| Number of | ||||
| chambers | 1 | 2 | 3 | |
| Working | ||||
| pressure | 50 mmHg | 50 mmHg, 40 mmHg | LEG: 20-60mmHg | |
| FOOT: 120-140mmHg | Different | |||
| Similar and less | ||||
| than the reference | ||||
| device. | ||||
| System | ||||
| diagnostics | Audible and visual alarms prompt recognition | |||
| of system faults | Audible and visual alarms prompt recognition | |||
| of system faults | Not available | Same | ||
| Leg cuffs | ||||
| material | PVC bladder covered with brushed Nylon | PVC bladder covered with brushed Nylon | Not available | Same |
| Leg cuff Sterile | ||||
| /Not Sterile | Clean / non sterile | Clean / non sterile | Clean / non sterile | Same |
| Leg cuff usage | Single patient use | Single patient use | Single patient use | Same |
| Battery | 3.7 V Li-ion Battery | 3.7 V Li-ion Battery | 3200mAh, 3350mAh | Same |
| Power | ||||
| Requirement | Rechargeable battery and/or AC | Rechargeable battery and/or AC | Rechargeable Battery and/or AC | Same |
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H. Summary of Non-Clinical Test
Non-clinical tests were conducted to verify that the proposed device met all design specifications as same to the predicate device.
Performance tests
The following tests were conducted to verify that the device design meet its function and performance requirements.
- Appearance test
- Button function test
- Alarm function test
- Pressure delivery test
- Time parameter test
- Battery charging test
- Noise test
- Bust and leak test
Biocompatibility
The sleeve parts are directly contact human body. Biocompatibility testing including Cytotoxicity, Sensitization and Irritation were conducted and the test results showed the material is non-toxic, non-sensitizing and non-irritating.
Electrical Safety and Electromagnetic Compatibility (EMC)
EMC tests were conducted according to the following standards:
• IEC 60601-1: 2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• IEC 60601-1-6:2010 Medical electrical equipment Part 1-6: General requirements for safety - Collateral Standard: Usability including IEC 62366: Application of usability engineering to medical devices
• IEC 60601-1-11: 2015 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
Software Verification and Validation
The software was considered as a "moderate" level of concern and had been verified and validated by the manufacturer.
l. Summary of Clinical Test
No clinical study is included in this submission.
J. Conclusion
Based on the comparison and analysis above, the proposed device is same or similar in design, intended use, technological characteristics to the predicate device. Differences between the subject device and predicate devices did not raise any new concerns regarding safety and effectiveness.
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The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.