(302 days)
Intended 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.
- Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.
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.
Here's an analysis of the provided text regarding the Artrocool®-S Water Circulating Cold Pack, focusing on acceptance criteria and the study that proves its effectiveness, as per your requested format:
Important Note: The provided document is a 510(k) Premarket Notification for a medical device (Artrocool®-S Water Circulating Cold Pack). It establishes "substantial equivalence" to legally marketed predicate devices, rather than directly demonstrating novel performance through a clinical trial with specific acceptance criteria. Therefore, some of your requested points, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set," are not applicable to this type of submission, as it doesn't involve AI or a traditional clinical study to prove efficacy in the same way a new drug or diagnostic might.
The "study" in this context is the comparison of the device's features and performance parameters to those of existing, legally marketed predicate devices to establish substantial equivalence.
1. Table of Acceptance Criteria and the Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, there aren't explicit "acceptance criteria" in the traditional sense of a clinical trial's primary endpoint. Instead, the acceptance criteria are implicitly defined by the characteristics and performance of the predicate devices that the Artrocool®-S is compared against. The "reported device performance" is essentially how the Artrocool®-S aligns with or performs similarly to these predicate devices.
| Feature | Acceptance Criteria (from Predicate Devices) | Reported Artrocool®-S Performance |
|---|---|---|
| Intended Use | Trauma, orthopaedics, sports medicine, rheumatology, general, plastic and reconstructive surgery, chirosurgery and neurology | Trauma, orthopaedics, sports medicine, rheumatology, general, plastic and reconstructive surgery, chirosurgery and neurology |
| Cooling Time | Approx. 6-10 hours (depending on predicate) | Approx. 8 hours at 43°F (continuous use) |
| Cold Source | Water - Ice / Frozen Gel | Water - Ice (via frozen water bottle) |
| Operating Temperature Range | Varies (e.g., 32°F - 70°F or Minimum temp. 38°F) | 39°F to 59°F depending on ambient air temp |
| Power Supply | 6 VDC from 115/230 VAC 50/60 Hz or 12 VDC from 110 VAC 60Hz | 6 VDC from 115/230 VAC 50/60 Hz |
| Ground Leakage Current | <55 micro-amps | <55 micro-amps |
| Recirculating Fluid | Water / 4:1 mixture of water and alcohol | 4:1 mixture of water and alcohol - 250 ml. |
| Disposable Cuff Covers | Yes | Yes |
| Cuff Styles/Sizes | 1 to 5 styles/sizes (depending on predicate) | 5 styles/sizes |
| Performance Standards | UL-544 (for powered units) | UL-544 |
| Weight | Approx. 8 to 24 lb. filled (depending on predicate) | Approx. 12.75 lb. filled |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a "test set" in the sense of a clinical or analytical study with a specific sample size of patients or data. The "test" is the comparison itself against the specifications and performance of legally marketed predicate devices.
- Sample Size: Not applicable. The "test" is a regulatory comparison.
- Data Provenance: The data comes from the specifications and characteristics of the existing predicate devices (Theracool™, Polar Care™, Dr. Kool™, Cryo Cuff™) and the engineering specifications of the Artrocool®-S. This is retrospective in the sense that it relies on previously established devices and the design of the new device. The country of origin for the predicate devices isn't specified in detail, but the Artrocool®-S is from Germany (ORMED, GMBH).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The "ground truth" for a 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. There wouldn't be a panel of experts specifically establishing "ground truth" for a test set in this context. The FDA's review process itself relies on regulatory experts.
4. Adjudication Method for the Test Set
Not applicable. There's no "adjudication method" in the context of human interpretation of a device's output for establishing ground truth, as would be seen in an imaging study. The comparison is based on objective device specifications and intended use.
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 device (cold pack), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study or AI-related performance metrics are irrelevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Not applicable, for the same reasons as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" is the regulatory precedent of the predicate devices. The FDA assesses whether the new device is "substantially equivalent" in terms of its intended use, technological characteristics, and safety/effectiveness profile to devices already on the market. There's no specific pathology, outcomes data, or expert consensus (beyond the regulatory review) invoked for a new clinical determination.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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ັນປີ 2 9 ເຮືອ
Attachment III
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- 11
Revised Summary of Safety and EFFECTIVENESS INFORMATION
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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.
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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® | TheracoolTM | Polar Care™ | Dr. Kool™ | Cryo Cuff™ | SE? |
|---|---|---|---|---|---|---|
| Intended Use | Trauma, orthopaedics,sports medicine,rheumatology, general,plastic andreconstructive surgery,chirosurgery andneurology | Same | Same | Same | Same | Yes |
| Cooling Time | Approx. 8 hours at43°F | Up to 9½hours | Approx. 8hours | Up to 10hours | Approx. 6-8hours | Yes |
| Cold Source | Water - Ice | Water - Ice | Water - Ice | Frozen Gel | Ice & Water | Yes |
| OperatingTemperatureRange | 39°F to 59°F dependingon ambient air temp | Unstated | 32°F - 70°Fdepending onambient airtemp | Minimumtemp. 38°F | Unstated | Yes |
| Power Supply | 6 VDC from 115/230VAC 50/60 Hz | 12 VDC from110 VAC60Hz | 12 VDC from110 VAC 60Hz | 12 VDC from110 VAC60Hz | Gravity flowonly | Yes |
| GroundLeakageCurrent | <55 micro-amps | <55 micro-amps | <55 micro-amps | <55 micro-amps | <55 micro-amps | Yes |
| RecirculatingFluid | 4:1 mixture of waterand alcohol - 250 ml. | Water | Water - | Water | Water | Yes |
| Disposable cuffcovers | Yes | Yes | Yes | Yes | Yes | Yes |
| Cuff | 5 styles/sizes | 1 multi-useuniversal | 4 styles, 4sizes | 3 styles, 1size ea. | 4 styles, 2sizes ea | Yes |
| PerformanceStandards | UL-544 | UL-544 | UL-544 | UL-544 | Non-electric | Yes |
| Weight | Approx. 12.75 lb. filled | Approx. 8 to12 lb. filled | Approx. 24 lb.w/ cooler | Approx. 8.9lb. filled | Approx. 10 lb.filled | Yes |
9
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.
ា
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 Requlatory Class: II Product Code: ILO Dated: July 27, 1997 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 Requlations, 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 requlation may result in requlatory action. In addition, FDA may publish further announcements 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 regulations.
- 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 diaqnostic 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 one regaration bronorion" (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,
[signature]
Celia 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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K964354 510(k) Number:
artrocool™ Water Circulating Cold Pack Device Name:
Intended 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.
-
- Treatment of pain and swelling caused by musculoskeletal contusions and athletic injury.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Genarsi Pisatorethe De964354
510(k) Number
Prescription Use __ OR Over-The-Counter Use
(Per 21 CFR 801.109) (Optional format 1-2-96)
§ 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.