(302 days)
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Not Found
No
The device description and lack of mentions of AI/ML terms indicate it is a standard cryotherapy device without AI/ML components.
Yes
The device is intended for the treatment of pain and swelling related to various medical conditions, indicating a therapeutic purpose.
No
The device is described as a localized cold therapy device for pain and swelling, not for diagnosing conditions. Its operation involves recirculating cold liquid and does not involve any diagnostic functions.
No
The device description clearly outlines a physical hardware system including an insulated chest, pump, tubing, and cuffs, which are essential components for its function. It is not solely software.
Based on the provided information, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Artrocool® - S is a cryotherapy device that applies localized cold therapy externally to the body. It does not analyze any biological specimens.
- Intended Use and Indications: The intended use and indications for use clearly describe the application of cold therapy for pain and swelling related to musculoskeletal conditions and post-surgical recovery. These are external therapeutic applications, not diagnostic procedures involving in vitro analysis.
Therefore, the Artrocool® - S falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-
- Localized cold therapy for post-traumatic and post-surgical medical and or surgical conditions.
Indications For Use:
-
- Treatment of pain and swelling of acute periarticular processes.
-
- Treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia.
-
- Treatment of pain and swelling postoperatively for bones, joints and soft tissue.
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- Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.
Product codes (comma separated list FDA assigned to the subject device)
89ILO
Device Description
The Artrocool® - S is a typical cold liquid recirculating cryotherapy device. The Artrocool® -S is an insulated ice chest-like box with a closed loop liquid recirculating pump and tubing. The tubing connects to a variety of cuffs designed to be placed on or around injured or post surgical body structures, limbs or joints. The device operates by the use of a water filled cartridge and an insulated chest. The water filled bottle is frozen solid prior to first use. When the bottle is frozen, it is placed within the insulated chamber of the Artrocool. A 4:1 mixture of water and alcohol is poured into the fluid reservoir (balancing container) until full. The pump is circulated with the connecting tubing and cuff attached. Once both are filled and all air bubbles have been purged from the system the unit is ready for service.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
body structures, limbs or joints
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
§ 890.5720 Water circulating hot or cold pack.
(a)
Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.
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ັນປີ 2 9 ເຮືອ
Attachment III
ﺘﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮ
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Revised Summary of Safety and EFFECTIVENESS INFORMATION
1
Summary of Safety and Effectiveness Inform Section 510(k) Premarket Notification ORMED, GMBH
Requlatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
- Artrocool®-S Water Circulating Cold Pack 1. Device Trade Name:
-
- Common Name: Water Circulating Cold Pack
Classification Name: Water Circulating Cold Pack
3. Establishment Name & Registration Number:
Merzhauser Strasse 112 D-79100 Freiberg I. B. Germany 011 49 7 61/45 84 471 (voice) 011 49 7 61/45 84 450 (fax)
Reg. Number: 2247872
4. Classification:
§ 890.5720 Water circulating hot or cold pack. (a) Identification. A water circulating hot or cold pack is a device intended for medical purposes that operates by pumping heated or chilled water through a plastic bag and that provides hot or cold therapy for body surfaces. (b) Classification. Class II (performance standards).
Product Code: 89ILO
Device Class: Class II
Classification Panel: Physical Medicine
5. Contact Person:
Mrs. Margit Bayha ORMED, GMBH Merzhauser Strasse 112 D-79100 Freiberg I. B. Germany 011 49 7 61/45 84 471 (voice) 011 49 7 61/45 84 450 (fax)
6. Special Controls:
Special controls have not been established for this device.
2
7. Device Description:
The Artrocool® - S is a typical cold liquid recirculating cryotherapy device. The Artrocool® -S is an insulated ice chest-like box with a closed loop liquid recirculating pump and tubing. The tubing connects to a variety of cuffs designed to be placed on or around injured or post surgical body structures, limbs or joints. The device operates by the use of a water filled cartridge and an insulated chest. The water filled bottle is frozen solid prior to first use. When the bottle is frozen, it is placed within the insulated chamber of the Artrocool. A 4:1 mixture of water and alcohol is poured into the fluid reservoir (balancing container) until full. The pump is circulated with the connecting tubing and cuff attached. Once both are filled and all air bubbles have been purged from the system the unit is ready for service.
Substantially Equivalent Device(s): 8.
The Artrocool®-S is substantially equivalent to the Theracool™ Water Circulating Cold Pack, the Polar Care™ Water Circulating Cold Pack, the Dr. Kool™ Water Circulating Cold Pack and the Cryo Cuff™ Water Circulating Cold Pack.
9. Comparison to Predicate Device(s):
With the exception of the Cryo Cuff™ which is a gravity flow device, the Artrocool®-S and the remaining cold therapy units utilize a small DC electric pump to circulate and recirculate a chilled fluid through an assortment of body contact pads or cuffs. All of the powered units including the Artrocool® S are UL-544 compliant. The water circulating electric pump has a ground current leakage value of less than 55 micro-amps.
None of the units depend on direct refrigeration of the circulating liquid. The Dr. Kool™ and the Artrocool® -S utilize a container of frozen water or chemical gel to cool the isolated recirculating liquid. The rest of the units circulate melt water throughout the system.
The intended uses of all of the units are essentially the same and include conditions like trauma, orthopaedic surgery, sports medicine injuries and rehabilitation, rheumatology, general, plastic and reconstructive surgery, chirosurgery and neurology. All the devices are suitable for any traumatic, medical or surgical conditions benefiting from cold therapy.
The duration of therapeutic cold conditions for all of the units is variable depending on issues like pad/cuff size, ambient temperature, patient temperature, etc. Time duration of useful cold therapy for the comparison units is from 1 ½ to 10 hours. The Artrocool® -S provides cooling for 6 to 8 hours of continuous use.
10. Packaging:
Standard, paper fiber industry typical bulk shipper packaging is utilized. The packaging selected for use is sufficient to identify, protect and transport the device safely.
11. Sterilization/Re-sterilization:
May not be sterilized or re-sterilized. Surface disinfection is possible using commercially available non-solvent based disinfectant products. Cleaning and sanitizing instructions are supplied with each Artrocool®-S unit.
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Conclusion: 12.
.. .
Based on the materials, intended uses, design, and effectiveness, the Artrocool®-S Bussu on the materials, whichedulivalent to the referenced legally marketed comparison graphically The feature comparison chart below water circulating cold packs. demonstrates this equivalence.
13. Feature Comparison Table:
| FEATURE | Artrocool® | Theracool
TM | Polar Care™ | Dr. Kool™ | Cryo Cuff™ | SE? |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|----------------------------------------------------|--------------------------------|--------------------------|-----|
| Intended Use | Trauma, orthopaedics,
sports medicine,
rheumatology, general,
plastic and
reconstructive surgery,
chirosurgery and
neurology | Same | Same | Same | Same | Yes |
| Cooling Time | Approx. 8 hours at
43°F | Up to 9½
hours | Approx. 8
hours | Up to 10
hours | Approx. 6-8
hours | Yes |
| Cold Source | Water - Ice | Water - Ice | Water - Ice | Frozen Gel | Ice & Water | Yes |
| Operating
Temperature
Range | 39°F to 59°F depending
on ambient air temp | Unstated | 32°F - 70°F
depending on
ambient air
temp | Minimum
temp. 38°F | Unstated | Yes |
| Power Supply | 6 VDC from 115/230
VAC 50/60 Hz | 12 VDC from
110 VAC
60Hz | 12 VDC from
110 VAC 60Hz | 12 VDC from
110 VAC
60Hz | Gravity flow
only | Yes |
| Ground
Leakage
Current |