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.

Device Description

The ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY unit 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. 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. A high temperature alarm is utilized to warn of temperatures in excess of the +50 °C.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the ORMED, GMBH - ARTROTHERM CRYOTHERAPY AND THERMOTHERAPY UNIT. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through a dedicated study with acceptance criteria and detailed performance metrics as would be found in a clinical trial report for an innovative device.

Therefore, the document does not contain the requested information regarding specific acceptance criteria for a study, the detailed results of such a study, sample sizes for test or training sets, data provenance, expert qualifications for ground truth establishment, adjudication methods, or MRMC comparative effectiveness study results.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices (TTU-100 by Danninger Medical Technology, Inc. and Hot/Ice® HE500/A by ThermoTemp, Inc.) based on device features, intended use, and technical specifications.

Here's a breakdown of what the document does provide, addressing the spirit of your request within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance:

The document includes a "Comparison Table" (Section 13) which serves a similar purpose to an acceptance criteria table in a 510(k) by demonstrating that the new device's features and performance are "substantially equivalent" to predicate devices. It doesn't present "acceptance criteria" in the sense of predefined thresholds for a study outcome, but rather compares the ARTROTHERM's specifications to those of its predicates.

FEATURE	ARTROTHERM™	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 Ranges:	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:	<55 micro-amps	<55 micro-amps	<55 micro-amps	Yes
Weight:	22 lb.	23 lb.	21 lb.	Yes
Recirculating Fluid:	Water/alcohol, 80%/20% mixture	Distilled water, water/alcohol mix for cleaning and maintenance only	Water/alcohol mix 70%/30%	Yes
Performance Standards:	UL/ETL compliant	UL/ETL compliant	UL/ETL compliant	Yes
Disposable cuff covers:	Yes	Yes	Yes	Yes
Safety:	Grounded, fused & overload protected Auditory alarm - water for temp above 122°F	Automatic shutoff above 116°F or below 35°F water outlet temperature, Low water level or unit tilt greater than 45°	Low fluid, no- fluid flow, high/low temperature extreme and blocked air flow indicator lights	Yes
Manufacturer:	Medireha	Danninger	ThermoTemp, Inc.	Yes

Summary of How Device Meets Criteria:
The table explicitly states "Yes" under the "SE?" (Substantially Equivalent) column for all features, indicating the applicant's claim that the ARTROTHERM™ meets the equivalence standard against the predicate devices based on these performance and design characteristics. For example, the temperature ranges are compared, and while not identical, they are deemed equivalently suitable for the intended therapeutic use. Similarly, electrical safety standards (UL-544 requirements, ground leakage current) are noted as equivalent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a medical device that achieves substantial equivalence through comparison of design and performance specifications to predicate devices, not through a clinical "test set" in the sense of patient data.

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)
Not applicable. Ground truth as typically understood for clinical studies involving expert review is not relevant here. The "ground truth" for this submission are the established specifications, intended uses, and safety profiles of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set is discussed.

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
Not applicable. This device is a physical therapy unit, not an AI-assisted diagnostic or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, it's a physical device. Its "standalone" performance is implicitly covered by the technical specifications and safety features described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is the established regulatory acceptance and performance of the identified predicate devices (TTU-100 and Hot/Ice® HE500/A). Substantial equivalence is determined by comparing the new device's features, intended use, and technical specifications against these legally marketed devices.

8. The sample size for the training set
Not applicable. No "training set" in the context of machine learning or complex statistical modeling is mentioned or relevant for this type of device and submission.

9. How the ground truth for the training set was established
Not applicable.

Summary

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AUG 2 9 1997

K964799

Attachment III

Revised Summary of Safety and EFFECTIVENESS INFORMATION

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K964799

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

1. Device Name:
  ARTROTHERM™ CRYOTHERAPY AND THERMOTHERAPY Trade 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.

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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:

1. 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 posttraumatic and postsurgical medical and orsurgical conditions.	Same	Same	Yes
Cuff:	5 styles/sizes	3 styles/sizes	5 styles/sizes	Yes
Water TempControl:	Rheostat	Digital	Digital	Yes
Water TempIndicator:	LCD	LCD	LED	Yes
TemperatureRange(s):	43°F to 122°F, userselectable	35°F -116°F userselectable in 1°increments	40°F -105°F userselectable in 1°increments	Yes
ElectricalRequirements:	110 -120 VAC 50/60 Hz 220-230 VAC 50 Hz	120 VAC 60 Hz	115 VAC 50/60 Hz230 VAC 50/60 Hz	Yes
Ground LeakageCurrent Value:	<55 micro-amps	<55 micro-amps	<55 micro-amps	Yes
Weight:	22 lb.	23 lb.	21 lb.	Yes
RecirculatingFluid:	Water/alcohol, 80%/20%mixture	Distilled water,water/alcohol mix forcleaning andmaintenance only	Water/alcohol mix70%/30%	Yes
PerformanceStandards:	UL/ETL compliant	UL/ETL compliant	UL/ETL compliant	Yes
Disposable cuffcovers:	Yes	Yes	Yes	Yes
Safety:	Grounded, fused & overloadprotected Auditory alarm -water for temp above 122°F	Automatic shutoff above116°F or below 35°Fwater outlet temperature,Low water level or unittilt greater than 45°	Low fluid, no- fluidflow , high/lowtemperature extremeand blocked air flowindicator lights	Yes
Manufacturer:	Medireha	Danninger	ThermoTemp, Inc.	Yes

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. The bottom half of the circle features a stylized eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

.. J

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David W. Schlerf ·Buckman Company, Inc. Representing Ormed, GmBH 1000 Burnett Avenue, Suite 450 Concord, California 94520

Re: K964354 Artrocool®-S Water Circulating Cold Pack K964799 Artrotherm™ Cryotherapy and Thermotherapy Regulatory Class: II Product Code: ILO July 27, 1997 Dated: Received: July 29, 1997

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, subject to the general controls provisions of the Act. 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.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major requlations affecting your devices can be found in the Code of Federal Requiations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. David W. Schlerf

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your devices as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

scollefa

ia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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	Separate of the contrôle de contrôlected to the contrôlegal de line of the comments of the comments of the comments of the comments of the comments of the contribution of the		4

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications For Use:

ું મુદ્દર્શન ్రా

100

ন্তু !

रुं।

্রে মু

Localized thermal therapy (hot or cold) for post traumatic and 1. post surgical medical and/or surgical conditions.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use
✓

(Per 21 CFR 801.109)

(Optional format 1-2-96)

Ormed/hot.doc

Regulation Number and Section

§ 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.