(273 days)
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Not Found
No
The device description focuses on basic thermal therapy mechanisms and safety features, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended for localized thermal therapy (hot or cold) to treat pain and swelling associated with various medical and surgical conditions, including post-traumatic and postoperative situations, musculoskeletal contusions, and athletic injuries. These are medical indications that aim to alleviate symptoms and promote recovery, thus classifying it as a therapeutic device.
No
The device description indicates it utilizes heating and cooling for therapeutic purposes (thermal therapy) and its intended use is for treatment of pain and swelling. There is no mention of it being used to diagnose conditions.
No
The device description explicitly details hardware components including a heating and cooling unit, tubing, thermal therapy cuffs/pads, and requires electrical current for operation.
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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY unit provides localized thermal therapy (hot or cold) directly to the body surface for pain and swelling management. It does not analyze any biological specimens.
- Intended Use: The intended use clearly describes the application of thermal therapy for post-traumatic and post-surgical conditions, not the analysis of biological samples.
- Device Description: The description details a heating and cooling unit, tubing, and thermal therapy cuffs/pads that are applied externally. There is no mention of components for collecting or analyzing biological specimens.
Therefore, the ARTROTHERM™ is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and or surgical conditions.
Indications for Use: 1) Treatment of pain and swelling of acute periarticular processes. 2) Treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia. 3) Treatment of pain and swelling postoperatively for bones, joints and soft tissue. 4) Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.
Product codes (comma separated list FDA assigned to the subject device)
8911 O
Device Description
The ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY unit also utilizes a small portable heating and cooling unit, a length of dual lumen connecting tubing and assorted thermal therapy cuffs/pads. The various cuff/pads of the ARTROTHERM™ are shaped to better contour to different body surfaces.
Therapy pads designed to accommodate the ankle, foot, wrist, hand, back, shoulder, hip, neck and knee are offered at present. The pads are held in place with straps and/or wraps.
Basic Operation: For the first set-up, the cap of the fluid reservoir is removed and a 4:1 solution of water and alcohol is poured into the unit. A premixed alcohol/water solution is available for use with the unit. With the pump running and the connecting tubing and cuff attached, the alcohol/water solution is poured in until the reservoir no longer pumps dry. When the air bubbles have been purged from the system, the reservoir will be about 3/4 full. Replace the fluid reservoir cap tightly, the unit is now ready for service. The cuff and tubing are equipped with sealing connectors and will remain filled after the initial set-up application. A few drops of fluid may escape when the cufflubing are disconnected, this is normal. Additional fluid is added to the reservoir whenever a new emply cuff is attached to the system for the first time.
The unit requires 110 -115 or 220-230 VAC 50/50Hz current for operation. The unit is fully electrically isolated and meets UL-544 requirements. The ground leakage current value for the water circulating electric pump is less than 55 micro-amps.
Minimum and maximum cooling and heating temperatures are affected by available environmental conditions, size of pad selected and patient temperature. Under typical conditions, best low temperature is +4 °C. Best low temperature is achieved after approximately 30 minutes of operation. Maximum high temperature is +50 °C and the unit requires about 15 minutes to reach this level. The heating cycle is generally less affected by environmental conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, foot, wrist, hand, back, shoulder, hip, neck and knee
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)
Not Found
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.
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.
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
§ 890.5720 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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AUG 2 9 1997
Attachment III
Revised Summary of Safety and EFFECTIVENESS INFORMATION
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| Section 510(k) Premarket Notification | For the ORMED, GMBH - ARTROTHERM |
|---|---|
| Summary of Safety and Effectiveness Information | CRYOTHERAPY AND THERMOTHERAPY UNIT |
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
-
- Device Name:
ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY Trade Name:
- Device Name:
Water Circulating Hot or Cold Pack Common Name:
Classification Name: Water Circulating Hot or Cold Pack
Establishment Name & Registration Number: 3.
Name: ORMED, GMBH
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) Class II (performance standards).
Product Code: 8911 O
Device Class: Class II
Classification Panel: Physical Medicine
5. Contact Person:
Mrs. Margit Bayha ormed, gmbh Merzhauser Strasse 112 D-79100 Freiberg 1. 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:
Intended Use: Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and or surgical conditions.
Indications for Use: 1) Treatment of pain and swelling of acute periarticular processes. 2) Treatment of pain and swelling following mobilization of shoulder stiffness under anesthesia. 3) Treatment of pain and swelling postoperatively for bones, joints and soft tissue. 4) Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.
Background: The ARTROTHERM" CRYOTHERAPY AND THERMOTHERAPY like the referenced equivalent devices, is a typical thermal therapy device. As a group, thermal therapy devices are capable of producing both heating and cooling effects depending on the therapy mode selected. Thus, it is possible to administer hot or cold therapy or hot & cold therapy in alternating fashion without removal and reapplication of different pieces of equipment.
Typical thermal therapy units consist of a compact heating and chilling unit equipped with a liquid circulating electric pump. The pump circulates a liquid (usually water or a water/alcohol mixture) around the heating/cooling elements or heat exchanger of the thermal therapy device. The heated or cooled liquid is then circulated to the treatment site via insulated tubing to a patient contact pad or cuff. Placement straps or wraps are used to hold the cuffipad in place during treatment. Frequently, standard elastic wraps (Ace-type bandages) are used to hold the cuff(pad in place.
Following the fashion of available devices, the ARTROTHERM™ AND THERMOTHERAPY unit also utilizes a small portable heating and cooling unit, a length of dual lumen connecting tubing and assorted thermal therapy cuffs/pads. The various cuff/pads of the ARTROTHERM" are shaped to better contour to different body surfaces.
Therapy pads designed to accommodate the ankle, foot, wrist, hand, back, shoulder, hip, neck and knee are offered at present. The pads are held in place with straps and/or wraps.
Basic Operation: For the first set-up, the cap of the fluid reservoir is removed and a 4:1 solution of water and alcohol is poured into the unit. A premixed alcohol/water solution is available for use with the unit. With the pump running and the connecting tubing and cuff attached, the alcohol/water solution is poured in until the reservoir no longer pumps dry. When the air bubbles have been purged from the system, the reservoir will be about 3/4 full. Replace the fluid reservoir cap tightly, the unit is now ready for service. The cuff and tubing are equipped with sealing connectors and will remain filled after the initial set-up application. A few drops of fluid may escape when the cufflubing are disconnected, this is normal. Additional fluid is added to the reservoir whenever a new emply cuff is attached to the system for the first time.
The unit requires 110 -115 or 220-230 VAC 50/50Hz current for operation. The unit is fully electrically isolated and meets UL-544 requirements. The ground leakage current value for the water circulating electric pump is less than 55 micro-amps.
Minimum and maximum cooling and heating temperatures are affected by available environmental conditions, size of pad selected and patient temperature. Under typical conditions, best low temperature is +4 °C. Best low temperature is achieved after approximately 30 minutes of operation. Maximum high temperature is +50 °C and the unit requires about 15 minutes to reach this level. The heating cycle is generally less affected by environmental conditions.
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A high temperature alarm is utilized to warn of temperatures in excess of the +50 °C. There is no automatic high temp system shut off, the device is to be shut off and removed by the patient or operator when the high temperature alarm sounds.
8. Substantially Equivalent Device(s):
The artrotherm" Cryotherapy and Thermotherapy is substantially equivalent to the following devices:
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- TTU-100 by Danninger Medical Technology, Inc.
- Hot/Ice® HE500/A by ThermoTemp, Inc.
9. Comparison to Predicate Device(s):
Two currently available therapy devices have been selected for comparison with the artrotherm" Cryotherapy and thermotherapy. The first is the TTU-100 Thermal Therapy Unit from Danninger Medical Technology, Inc. The second device is called the Hotlice® HE500/A made by ThermoTemp, Inc.
Minimum and maximum operation temperatures are 35° and 116° F. for the TTU-100 and 40° to 105° F. for the Hotice unit. These temperature ranges compare equivalently to the ARTROTHERM" CRYOTHERAPY AND THERMOTHERAPY unit temperature range of 43° to122° F. The intended use of all three units are the same. All devices provide localized heating or cooling therapy to selected body surfaces. Hot or cold therapy is useful in treating various traumatic or surgical conditions related to orthopaedics, sports medicine, rheumatology, general surgery, plastic surgery, reconstructive surgery, chirosurgery, foot surgery and selected neurology conditions.
Water temperature control is accomplished by rheostat in the ARTROTHERM" device and by digital controls in both of the comparison devices. This slight difference in temperature control mechanism is unimportant because either control is adequate . Water temp display is digital for all three devices utilizing either LCD or LED display characters.
All three units function on standard electrical outlet current of 120 VAC 60 Hz, though both the ARTROTHERM "and the Hotlice" HE500/A units will operate on 220-230 VAC 50/60 Hz current as well. All three units meet UL-544 requirements for electrical safety. All three units are grounded, safety fused and overload protected. The ground leakage current value for the ARTROTHERM® and the comparison units is less than 55 micro-amps.
The weight of all three units is essentially the same, being 21, 23 and 22 pounds respectively.
The circulating heat transfer fluid for the units is equivalent. A water alcohol mixture is used in the ARTROTHERM" (80%-20%) and the Hotlice® HE500/A (70%-30%) units while only distilled water is used in the TTU-100 Thermal Therapy unit. The TTU-100 Thermal Therapy unit uses a water alcohol mixture for cleaning and maintenance.
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.
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11. Sterilization/Re-sterilization:
The device may not be sterilized or re-sterilized. Surface disinfecting is possible using commercially available non-solvent based disinfectant products. Cleaning and sanitizing instructions are supplied with each ARTROTHERM™ unit.
12. Conclusion:
Based on the materials, intended uses, design, and effectiveness, the ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY unit is equivalent to the referenced legally marketed comparison water circulating cold packs. The feature comparison chart below graphically demonstrates this equivalence.
13. Comparison Table:
| FEATURE | ARTROTHERMTM | TTU-100 | Hot/Ice® | SE? |
|---|---|---|---|---|
| Intended Use: | Localized thermal therapy | |||
| (hot or cold) for post | ||||
| traumatic and post | ||||
| surgical medical and or | ||||
| surgical conditions. | Same | Same | Yes | |
| Cuff: | 5 styles/sizes | 3 styles/sizes | 5 styles/sizes | Yes |
| Water Temp | ||||
| Control: | Rheostat | Digital | Digital | Yes |
| Water Temp | ||||
| Indicator: | LCD | LCD | LED | Yes |
| Temperature | ||||
| Range(s): | 43°F to 122°F, user | |||
| selectable | 35°F -116°F user | |||
| selectable in 1° | ||||
| increments | 40°F -105°F user | |||
| selectable in 1° | ||||
| increments | Yes | |||
| Electrical | ||||
| Requirements: | 110 -120 VAC 50/60 Hz 220- | |||
| 230 VAC 50 Hz | 120 VAC 60 Hz | 115 VAC 50/60 Hz | ||
| 230 VAC 50/60 Hz | Yes | |||
| Ground Leakage | ||||
| Current Value: |