(115 days)
The device is indicated for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as: Primary lymphedema, edema following trauma and sport injures, Postimmobilization edema, Venous insufficiencies, Lymphedema.
Power Q1000 Premium is used with four chamber garments for full leg, and period has its own variable duration pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators. Power Q1000 Premium is a pneumatic pressure treatment system that repeats expansion of sleeves to help blood circulation and prevent blood clots or clogs.
The provided document does not describe the acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical or performance validation study for an AI/ML device.
Instead, this is a 510(k) summary for a Compressible Limb Therapy System (Power-Q1000 Premium), which is a physical medical device (a pneumatic pressure treatment system, essentially a massager). The acceptance criteria and "study" described here pertain to demonstrating substantial equivalence to a predicate device, primarily by showing compliance with recognized electrical safety and electromagnetic compatibility standards, and by comparing its technical specifications and intended use to the predicate.
Therefore, the requested information elements related to AI/ML device validation (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or available in this document.
Here's the information that can be extracted from the provided text, reframed to fit the request where possible, and noting where information is not relevant or available:
1. Table of acceptance criteria and the reported device performance
For this type of device (physical medical device, not an AI/ML diagnostic system), "acceptance criteria" primarily relate to compliance with recognized safety and performance standards for electrical medical equipment, and demonstrating comparable specifications to a predicate device.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|
| Safety and Performance Standards: | The Model Power-Q1000 Premium has tested and meets the requirements of the following standards: |
| EN60601-1, Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988/A1:91/A2:95) | Meets requirements. |
| EN60601-2-10, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators | Meets requirements. |
| EN60601-1-2, Medical electrical equipment - Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility | Meets requirements. |
| Functional Equivalence to Predicate Device (WHF-324 POWER-Q1000) | The device demonstrates substantial equivalence in intended use, indications for use, contraindications, mode of compression, number of chambers, and compression applicator garments. Minor differences exist in therapy time (0-99 min vs. 0-30 min for predicate) and maximum/minimum pressure (0-240 mmHg vs. 0-300 mmHg for predicate), but these do not raise new safety or effectiveness concerns. |
| Device Specifications/Performance Characteristics: | |
| Pressure (mmHg) | 0~240 mmHg |
| Mode Selection | A, B, C, D (D1, D2, D3, D4), E selection (Initial: Mode A) |
| Interval (sec) | 0, 5, 10, 15, 20, 25, 30 sec (Initial: 0 sec) |
| Time (min) | 5~99 min (Initial: 15 min) |
| Pressure Time (mmHg) | 0 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a physical medical device and not an AI/ML system requiring a clinical test set with patient data. The "testing" referred to is laboratory testing for compliance with electrical and safety standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Ground truth, in the context of an AI/ML system's diagnostic performance, is not relevant here. The ground truth for this device's safety and performance is established by its adherence to internationally recognized electrical safety and medical device standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical studies, particularly for diagnostic AI/ML devices.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. MRMC studies are specific to evaluating the impact of AI on human reader performance, which doesn't apply to this physical therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable, as it refers to an algorithm's performance, not a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's "performance" is its successful demonstration of compliance with the specified international safety and performance standards (EN60601-1, EN60601-2-10, EN60601-1-2). This is established through standard laboratory testing protocols defined by those standards.
8. The sample size for the training set
This information is not applicable as this is a physical medical device, not an AI/ML system that utilizes a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this physical medical device.
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FEB 2 7 2012
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510(k) Summary [As required by 807.92(c)]
Date of issue: Jan 25, 2012
A. 510k Number
- B. Applicant/Applicant Company Name: BSR KOREA Corp. Company Name: DSR ROREA Corp:
Address: Migun Techno World 2 C-dong, 524, #533-1 Yongsan-dong, Yuseong-gu, Daejeon, KOREA. Tel: 82-42-476-2977 Fax:82-42-476-2978 Contact person: Eileen Yang - C. Proprietary and Established Names: WONJIN MULSAN Co., Ltd. Address: 10B-7L 623-6 Namchon-dong, Namdong-gu Incheon, Korea
- D. Regulatory information
-
- Classification Name: Massager, Powered Inflatable Tube
-
- Common/Usual Name: Powered inflatable Tube Massager
-
- Proprietary Name: Compressible Limb Therapy System (Power-Q1000 Premium)
-
- Classification /Product Code: Class 2, IRP(21 CFR 890.5650)
-
- E. Intended Use
Power-Q1000 Premium is intended for use by medical professionals and patients at home, Fower-Q1000 Trennant is meeting many conditions, such as: Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.
F. Device Description
Device Deseription
Power Q1000 Premium is used with four chamber garments for full leg, and period has its own variable duration pressure, cycle time and gradient setting. Power unit features visual operation statusand fault indicators.
| Name | Power-Q1000 Premium |
|---|---|
| Pressure (mmHg) | 0~240mmHg |
| Mode | A, B, C, D(D1, D2, D3, D4), E selection. (The initial set : Mode A) |
| Interval | Interval : 0, 5, 10, 15, 20, 25, 30 sec, selection. (The initial set :0sec) |
| Time(min) | Time(min) : 5~99min, selection. (The initial set : 15min) |
| Pressure Time | Pressure : 0 |
Technological characteristics
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- H. Substantial Equivalence Information
- l. Predicate Device
- -510(k) Number: 100656
- l. Predicate Device
-510(R) Namber: 100050
-Name: Compressible Limb Therapy system(WHF-324 POWER-Q1000 PLUS) -Classification: 2
-
- Comparison with predicate _________________________________________________________________________________________________________________________________________________
| Model Name | Power Q1000 Premium | WHF-324 (POWER-Q1000) (predicate device) |
|---|---|---|
| 510(k) number | None yet | K100656 |
| Classification | Class II Device/ IRP (21 CFR 890. 5650) | Class II Device/ IRP (21 CFR 890. 5650) |
| Intended use | The device is indicated for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as: Primary lymphedema, edema following trauma and sport injures, Postimmobilization edema, Venous insufficiencies, Lymphedema. | The device is indicated for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as: Primary lymphedema, edema following trauma and sport injures, Postimmobilization edema, Venous insufficiencies, Lymphedema. |
| Description | Power Q1000 Premium is a pneumatic pressure treatment system that repeats expansion of sleeves to help blood circulation and prevent blood clots or clogs. | Power Q1000 PLUS is a pneumatic pressure treatment system that repeats expansion of sleeves to help blood circulation and prevent blood clots or clogs |
| Standard | EN ISO14971EN60601-1EN60601-2-10EN60601-1-2 | EN ISO14971EN60601-1EN60601-2-10EN60601-1-2 |
| Indications | Primary lymphedema, Edema following trauma and sport injuires, postimmobilization edema, Venous insufficiencies, Lymphedema. | Primary lymphedema, Edema following trauma and sport injuires, postimmobilization edema, Venous insufficiencies, Lymphedema. |
| Contraindications | Acute pulmonary edemaAcute throubophlebitisAcute congestive cardiac failureAcute infections, Deep vein thrombosisEpisodes of pulmonary embolism Wounds, lesions, or turmors at or in the vicinity of application | Acute pulmonary edemaAcute throubophlebitisAcute congestive cardiac failureAcute infections, Deep vein thrombosisEpisodes of pulmonary embolism Wounds, lesions, or turmors at or in the vicinity of application |
| Where increased venous andlymphatic return is undesirable,Bone fractures or dislocation ator in the vicinity of application | Where increased venous andlymphatic return is undesirable,Bone fractures or dislocation ator in the vicinity of application | |
| Mode of Compression | Sequential | Sequential |
| Power source | Electricity Supply: 220-240V50/60HZ | |
| Therapy Time | 0~99 minutes | 0-30 minutes |
| Maximum andMinimum Pressure | 0-240mm Hg | 0-300mm Hg |
| Number of Chambers | 4 Chambers for each unit | 4 Chambers for each unit |
| CompressionApplicator Garments | Nylon | Nylon |
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J. Performance characteristics
The Model Power-Q1000 Premium has tested and meets the requirements of the following standard.
-EN60601-1, Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988/A1:91/A2:9s)
-EN60601-2-10, Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
-EN60601-1-2, Medical electrical equipment - Part 1: General requirements for safety -Collateral standard: Electromagnetic compatibility
K. Conclusion
Compressible Limb Therapy System WHF-324 (POWER-Q1000 PLUS)) has substantial equivalent intended use as the-market-cleared WHF-314(POWER-Q1000) and has substantial equivalent technological and performance characteristics. After analyzing Substantial equivately "connerogen" it is the conclusion of WONJIN MULSAN Co., Idol that Compressible Limb Therapy System (WHF-324 (POWER-Q10 PLUS)) is as safe and effective as the predicate devices, has few technological differences, but there are no new and chective as the productions any new safety and/or effectiveness concerns. mentations for about that it substantially equivalent to the predicate devices
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB 2 7 2012
Wonjinmulsan Co., Ltd. % BSR Korea Ms. Eileen Yang D-524 Migun Techno World 2 533-1 Yongsan-Dongyuseong-Gu Daejeon Republic of Korea KS
Re: K113275
Trade/Device Name: Compressible Limb Therapy System Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: February 14, 2012 Received: February 14, 2012
Dear Ms. Yang:
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 I ou may , arons 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.
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Page 2 - Ms. Eileen Yang
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic' and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
all
Enclosure
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PJ 1.of1
INDICATIONS FOR USE
510(k) Number (if known):
Model No. POWER-Q1000 Premium Device Name: Compressible Limb Therapy System
Indications for Use:
The device is indicated for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as: Primary lymphedema, edema following trauma and sport injures, Postimmobilization edema, Venous insufficiencies, Lymphedema.
Prescription Use _ x (Part 21 CFR 801 Subpart D)
. AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
Page 1 of 1
510(k) Number. K113275
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).