Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.

VascuTherm Indications:

Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
Decrease the risk of deep venous thrombosis (DVT).
Aids the blood flow back to the heart.
Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.

Device Description

The NanoTherm device is comprised of a reusable pump (NanoTherm unit) and various single patient use inflatable wraps (NanoTherm Wraps). The VascuTherm device consists of a reusable pump (VascuTherm unit) and various single-patient use inflatable wraps (VascuTherm Wraps). The VascuTherm unit has additional equipment installed and specially designed wraps specifically for the preventive treatment of DVT.

The NanoTherm unit thermal control therapy provides chilled fluid and heated fluid to the therapy site to reduce pain and swelling and compresses the extremity to enhance performance and fluid transfer and treatment of edema and lymphedema.

The VascuTherm unit contains a DVT mode that is not present on the NanoTherm unit. This therapy mode is for air-only DVT compression therapy using air-only DVT wraps.

The NanoTherm and VascuTherm systems utilize microprocessor control with multiple sensors to ensure safety and system functionality, and to provide consistent and repeatable therapy modalities. Alarms are both visual on the unit display and audible. Alarms are in place to detect a potentially unsafe situation and to terminate therapy to prevent patient injury. Possible unsafe situations are listed in the risk and hazard analysis covered in Appendices 16.3.A and 16.3.B.

AI/ML Overview

This is a 510(k) premarket notification for the NanoTherm and VascuTherm systems, seeking to demonstrate substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial would for novel efficacy claims. Instead, it focuses on comparing the new device's technological characteristics and intended use to existing, legally marketed predicate devices.

Therefore, many of the requested points regarding acceptance criteria and studies are not applicable or cannot be extracted directly from this document.

Here's a breakdown of what can be inferred or stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a direct "acceptance criteria" table for the new devices in the sense of performance metrics to be met by a study. Instead, it presents a comparison of the new devices' characteristics (NanoTherm and VascuTherm) against predicate devices to demonstrate substantial equivalence. The acceptance criterion for a 510(k) is typically substantial equivalence, meaning the device is as safe and effective as a legally marketed predicate device.

The tables (Table 1, Table 3, and Table 5) provide comparisons of various parameters:

Parameter	NanoTherm and VascuTherm (Edema/Lymphedema Mode)	Predicate: Chatttanooga Group, Inc. PresSsion S III (K942796)	Inferred "Acceptance Criteria" / Comparator Values	Reported NanoTherm/VascuTherm Performance
Pump Pressure Range	30 mm Hg. ±5 mm Hg.	30-100 mm Hg. ±5 mm Hg.	Within range of predicate / Comparable pressure control	30 mm Hg. ±5 mm Hg.
Default Pressure	30 mm Hg.	User Selectable	Comparable default pressure setting / Functionality	30 mm Hg.
Cycle Time (Inflation)	20 seconds	5-120 seconds	Within range of predicate / Functionality	20 seconds
Cycle Time (Deflation)	40 seconds	5-60 seconds	Within range of predicate / Functionality	40 seconds
Indications for Use	(See full description below)	(See full description below)	Substantially similar indications	Substantially similar indications
UL Mark	UL 60601 Class II, Type B	Class I, Type BF	Compliance with relevant safety standards	UL 60601 Class II, Type B
CE Mark	IEC 60601-1, -1-1, -1-2	Not known	Compliance with relevant safety standards	IEC 60601-1, -1-1, -1-2

Parameter	VascuTherm (DVT Mode)	Predicate: Chatttanooga Group, Inc. PresSsion S III (K942796)	Predicate: MicroTek Medical Venodyne DVT Advantage Plus+ (K011318)	Predicate: KCI PlexiPulse All-in-1 System (K981311)	Inferred "Acceptance Criteria" / Comparator Values	Reported VascuTherm Performance
Pump Pressure Range	45-100 mm Hg. ±5 mm Hg.	30-100 mm Hg. ±5 mm Hg. (calf)	40-45 mm Hg. (calf/foot)	140-180 mm Hg. ±5 mm Hg. (foot)	Within range of various predicates / Comparable pressure control	45-100 mm Hg. ±5 mm Hg.
Default Pressure	45 mm Hg. (calf) / 100 mm Hg. (foot)	User Selectable	45 mm Hg.	160 mm Hg. (foot)	Comparable default pressure setting / Functionality	45 mm Hg. (calf) / 100 mm Hg. (foot)
Cycle Time (Inflation)	30 seconds	5-120 seconds	12 seconds	1-5 seconds	Within range of various predicates / Functionality	30 seconds
Cycle Time (Deflation)	30 seconds	5-60 seconds	48 seconds	20-60 seconds	Within range of various predicates / Functionality	30 seconds
Indications for Use	(See full description below)	(See full description below)	(See full description below)	(See full description below)	Substantially similar indications	Substantially similar indications
UL Mark	UL 60601 Class II, Type B	UL - Type BF, Class 1	Not Known	UL	Compliance with relevant safety standards	UL 60601 Class II, Type B
CE Mark	IEC 60601-1, -1-1, -1-2	Not Known	Yes	Not Known	Compliance with relevant safety standards	IEC 60601-1, -1-1, -1-2

Parameter	NanoTherm and VascuTherm (Thermal Therapy)	Predicate: Artrotherm Cryotherapy and Thermotherapy (K964799)	Inferred "Acceptance Criteria" / Comparator Values	Reported NanoTherm/VascuTherm Performance
Therapy Type	Heat/Cool	Heat/Cool	Same therapy type	Heat/Cool
Therapy Temperature (Heat)	105°F	122°F	Comparable temperature range	105°F
Therapy Temperature (Cold)	43°F to 49°F	43°F	Comparable temperature range	43°F to 49°F
Indications for Use	(See full description below)	(See full description below)	Substantially similar indications	Substantially similar indications

Parameter	NanoTherm/VascuTherm Wraps (Edema/Lymphedema)	Predicate: BioCompression Systems, Inc. BioComfort Garments (K043423)	Inferred "Acceptance Criteria" / Comparator Values	Reported NanoTherm/VascuTherm Performance
Material in Skin Contact	200 Denier Nylon Oxford	200 Denier Nylon Oxford	Same material	200 Denier Nylon Oxford
Sterile/Non-Sterile	Sterile and Non-Sterile	Sterile and Non-Sterile	Same sterility options	Sterile and Non-Sterile
Single Patient Use	Yes	Yes	Same usage model	Yes

Parameter	VascuTherm Air-Only Therapy Wraps (DVT)	Predicate: Aircast Vena Flow Sterile Disposable Cuffs (K023800)	Inferred "Acceptance Criteria" / Comparator Values	Reported VascuTherm Performance
Material in Skin Contact	DuPont Softesse® Medical Fabric	DuPont Softesse® Medical Fabric	Same material	DuPont Softesse® Medical Fabric
Sterile/Non-Sterile	Non-Sterile	Non-Sterile and Sterile	Comparable sterility options	Non-Sterile
Single Patient Use	Yes	Yes	Same usage model	Yes

Indications for Use (NanoTherm):

Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.

Indications for Use (VascuTherm):

Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
Decrease the risk of deep venous thrombosis (DVT).
Aids the blood flow back to the heart.
Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document is a 510(k) summary, which typically involves demonstrating substantial equivalence through comparison of technological characteristics and safety/performance data with predicate devices. It does not describe a clinical study or a test set with a specified sample size, data provenance, or patient population in the context of demonstrating performance against acceptance criteria for a novel therapeutic claim. The patient population for intended use is stated as "non-ambulatory adult".

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. The document does not describe a study involving expert assessment to establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The document does not describe a study involving adjudication.

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. The devices are intermittent, external pneumatic compression devices, not AI-powered diagnostic tools, so MRMC studies and AI assistance are irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device. "Standalone performance" in this context would refer to the device operating as intended, which is implied by the comparison to predicate devices and adherence to safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The submission is based on demonstrating substantial equivalence to predicate devices, focusing on design, materials, and intended use, rather than a clinical study requiring ground truth for novel performance claims.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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KC61866
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Section 5. 510(k) Summary

AUG 2 2 2006

APPLICANT [As Required by 21 CFR 807.92 a(1)]

Applicant:

Address:

Telephone Number:

ThermoTek, Inc.

1454 Halsey Way Carrollton, TX 75007

972-242-3232 972-446-1195 (fax)

Company Contact:

Tony Quisenberry President

June 21, 2006

Date:

DEVICE NAME [As Required by 21 CFR 807.92 a(2)]

Proprietary Name:

NanoTherm™ and VascuTherm™

Common Name:

Intermittent, External Pneumatic Compression Device

Classification Name:

Compressible Limb Sleeve (per 21 CFR section 870.5800)

IDENTIFICATION OF PREDICATE DEVICES

[As Required by 21 CFR 807.92 a(3)]

•	Chattanooga Group, Inc. PresSsion S III	K942796
•	KCI PlexiPulse® All-in-1 System	K981311
•	Aircast VenaFlow System Disposable Cuffsas bundled	K023800
•	Bio Compression Systems BioComfortGarments	K043423
•	MicroTek Medical Holdings, Inc.Venodyne DVT Advantage Plus+	K011318
•	Ormed Artrotherm Cryotherapy andThermotherapy	K964799 sited and currently exemptClass II, per 21 CFR 890.5720

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KC61866
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DEVICE DESCRIPTION [As Required by 21 CFR 807.92 a(4)]

Intended Use

The NanoTherm and VascuTherm systems are new devices that are intended to function as intermittent, external pneumatic compression devices. The intended therapy of the niconfiteen, envice is to aid in the reduction and control of edema including lymphedema of the upper and lower extremities and venous stasis ulcers. The intended therapy of the or the upper and were is to reduce the risk of the formation of deep venous thrombosis new Yasour nen a blood flow back to the heart via lower extremity limb compression in addition to the intended uses of the NanoTherm device.

Physical Description

The NanoTherm device is comprised of a reusable pump (NanoTherm unit) and various The Nation use inflatable wraps (NanoTherm Wraps). The VascuTherm device consists single patient use mixes of herm unit) and various single-patient use inflatable wraps (VascuTherm Wraps). The VascuTherm unit has additional equipment installed and specially designed wraps specifically for the preventive treatment of DVT.

Therapy Modality Used

I herapy modality Oba
The NanoTherm unit thermal control therapy provides chilled fluid and heated fluid to the The Nano Fierin and themity therapy site to reduce pain and swelling and compresses the writinou on an one on an enormance and fluid transfer and treatment of edema and lymphedema.

The VascuTherm unit contains a DVT mode that is not present on the NanoTherm unit. This therapy mode is for air-only DVT compression therapy using air-only DVT wraps.

Safety Features

Sancey Features
The NanoTherm and VascuTherm systems utilize microprocessor control with multiple r he Nano Filent and vansafety and system functionality, and to provide consistent and Sensors to choure panolalities. Alarms are both visual on the unit display and audible. repeatable therapy modentially unsafe situation and to terminate therapy to Alarms are in place to detect a possible in the situations are listed in the risk and hazard analysis covered in Appendices 16.3.A and 16.3.B.

STATEMENT OF INTENDED USE [As Required by 21 CFR 807.92 a(5)]

Patient Population

The NanoTherm and VascuTherm devices` intended patient population is a non-ambulatory adult.

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NanoTherm Indications:

Treatment of disorders associated with vascular or lymphatic insufficiency such as o . I reatment of disorders associated with rabonial ess ulcers, post-mastectomy edema and chronic lymphedema.
and chronic lymphedelha.
Reduction of edema associated with soft tissue injuries such as burns, postoperative ■ edema, and ligament sprains.
edema, and figallent splains.
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical в and/or surgical conditions.

NanoTherm Contraindications

Presumptive evidence of congestive heart failure 트
Presumptive evidence of congesting deep vein thrombosis or pulmonary embolism 트
Suspected/observed deep acute venal thrombosis (phlebothrombosis) 트
Suspected/observed inflammatory phlebitis process 트
Suspected/observed pulmonary edema l
Suspected/observed acute inflammations of the veins (thrombophlebitis) .
Suspected/observed decompensated cardiac insufficiency 트
Suspected/observed arterial dysregulation 트
Suspected/observed erysipelas ■
Suspected/observed carcinoma and carcinoma metastasis in the affected extremity 트
Suspected/observed decompensated hypertonia 보
Suspected/observed acute inflammatory skin diseases or infection 트
Suspected/observed venous or arterial occlusive disease .
Determine venous and lymphatic return is undesirable I
Suspected/observed patient has Raynaud's Disease I
Suspected/observed poor peripheral circulation b
Suspected/observed hypersensitivity to cold I
Patient therapy contact on extremity containing a fracture 트
Extremities that are not sensitive to pain ■

VascuTherm Indications:

nerm indications.
Treatment of disorders associated with vascular or lymphatic insufficiency such as ■ Treathent of disorders associated +1), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
and chrome fymphedema.
Reduction of edema associated with soft tissue injuries such as burns, postoperative . edema, and ligament sprains.
edema, and figativent sprains.
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical .. and/or surgical conditions.
Decrease the risk of deep venous thrombosis (DVT).
Aids the blood flow back to the heart. .
Alds the brood frow back to the neat:
Treat and assist healing of cutaneous ulceration (wounds), reduce would healing ■ Treat and assist healing of catalional (blood flow), reduce compartmental pressures, time, cimance arena (swelling), reduce the need for anticoagulant (blood thinning) medications.

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KC61866
Page 4 of 7

Treat and assist healing of cutaneous ulceration (wounds), reduce would healing I time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.

VascuTherm Contraindications

Presumptive evidence of congestive heart failure 트
Suspected/observed pre-existing deep vein thrombosis or pulmonary embolism 트
Suspected/observed deep acute venal thrombosis (phlebothrombosis) 트
Suspected/observed inflammatory phlebitis process 트
Suspected/observed pulmonary edema 트
Suspected/observed acute inflammations of the veins (thrombophlebitis) 트
Suspected/observed decompensated cardiac insufficiency ■
Suspected/observed arterial dysregulation 제
Suspected/observed erysipelas 이
Suspected/observed carcinoma and carcinoma metastasis in the affected extremity I
Suspected/observed decompensated hypertonia 1
Suspected/observed acute inflammatory skin diseases or infection 트
Suspected/observed venous or arterial occlusive disease 제
Determine venous and lymphatic return is undesirable 트
Suspected/observed patient has Raynaud's Disease 미
Suspected/observed poor peripheral circulation 트
Suspected/observed hypersensitivity to cold 비
Patient therapy contact on extremity containing a fracture 트
Extremities that are not sensitive to pain I

The following patients must use the NanoTherm or VascuTherm therapy systems for t he forlowing ptact therapy under the supervision of a physician if they are:

Individuals with extremities not sensitive to pain 메
Individuals with extremely low blood pressure .
Individuals with Raynaud's Disease I
Hypersensitive to cold I
Children
l Diabetics

Differences in Indications

Dirrerences in manoTherm and VascuTherm devices are the same as those for the predicate devices listed in the Tables 1, 3 and 5 below.

{4}------------------------------------------------

K061866
Page 5 of 7

TECHNOLOGICAL CHARACTERISTICS [As Required by 21 CFR 807.92 a(6)]

The NanoTherm and VascuTherm devices have the same performance characteristics as the predicate devices.

The pneumatic control circuitry is a microprocessor-controlled system. Multiple safety The plicultiatio control one system including: high and low temperature alarms, alarms for unit malfunction situations, and system malfunction overpressure safety via a pressure vent switch. Power is supplied via 110 VAC line current.

vent Switch. I ower is supplied the 110 is received in cooling from 43°F to 49° and to 105°F in heating mode.

Comparison of features and principles of operation between the NanoTherm and Comparison of teatures and the predicate devices per Section 510(k) of the Act.

Table 1. Summary of Edema/Lymphedema Therapy Modality Comparison for the Units
Parameter	NanoTherm and VascuThermfor edema/lymphedema only	Chatttanooga Group, Inc.PresSsion S III (K942796)
Pump Pressure Range	30 mm Hg. ±5 mm Hg.	30-100 mm Hg. ±5 mm Hg.
Default Pressure	30 mm Hg.	User Selectable
Cycle Time	Inflation: 20 secondsDeflation: 40 seconds	Inflation: 5-120 secondsDeflation: 5-60 seconds
Indications for Use	Compression therapy is indicated forthe following:Treatment of disorders associated withvascular or lymphatic insufficiencysuch as Chronic Venous Insufficiency(CVI), venous stasis ulcers, post-mastectomy edema and chroniclymphedema.Reduction of edema associated withsoft tissue injuries such as burns,postoperative edema, and ligamentsprains. (K942796)	Compression therapy is indicated forthe following:Treatment of disorders associated withvascular or lymphatic insufficiencysuch as Chronic Venous Insufficiency(CVI), venous stasis ulcers, post-mastectomy edema and chroniclymphedema.Reduction of edema associated withsoft tissue injuries such as burns,postoperative edema, and ligamentsprains.Decrease the risk of deep venousthrombosis (DVT).
UL Mark	UL 60601 Class II, Type B	Class I, Type BF
CE Mark	IEC 60601-1 (safety)IEC 60601-1-1 (Emissions, Class A)IEC 60601-1-2 (Immunity)	Not known

na Therany Modality Comparison for the Units

f Edema/Lymphedema Biocompatibility Comparison for the Wraps

Table 2. Summary of Edema/Lymphedema Biocompatibility Comparison
Parameter	Therapy wraps foredema/lymphedema only	BioCompression Systems,Inc. BioComfort Garments(K043423)
Material in Skin Contact	200 Denier Nylon Oxford	200 Denier Nylon Oxford
Sterile/Non-Sterile	Sterile and Non-Sterile	Sterile and Non-Sterile
Single Patient Use	Yes	Yes

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K061866
Page 6 of 7

Parameter	VascuTherm	ChatttanoogaGroup, Inc.PresSsion S III(K942796)	MicroTekMedicalVenodyne DVTAdvantage Plus+(K011318)	KCI PlexiPulse All-in-1 System(K981311)
PumpPressureRange	45-100 mm Hg. ±5 mmHg.	30-100 mm Hg. ±5 mmHg. (calf therapy only)	40-45 mm Hg.(calf and foottherapy)	140-180 mm Hg. ±5mm Hg. (foot therapyonly)
DefaultPressure	45 mm Hg. (calf)100 mm Hg. (foot)	User Selectable	45 mm Hg.	160 mm Hg. (foottherapy only)
Cycle Time	Inflation: 30 secondsDeflation: 30 seconds	Inflation: 5-120secondsDeflation: 5-60 seconds	Inflation: 12 secondsDeflation: 48seconds	Inflation: 1-5 secondsDeflation 20-60seconds
Indicationsfor Use	Decrease the risk of deepvenous thrombosis, DVT.(K942796, K011318,K981311)Aids the blood flow backto the heart. (K011318)Treat and assist healing ofcutaneous ulceration(wounds), reduce wouldhealing time, enhancearterial circulation (bloodflow), reducecompartmental pressures,reduce edema (swelling),reduce the need foranticoagulant (bloodthinning) medications.(K981311)	Compression therapy isindicated for thefollowing:Treatment of disordersassociated with vascularor lymphaticinsufficiency such asChronic VenousInsufficiency (CVI),venous stasis ulcers,post-mastectomy edemaand chroniclymphedema.Reduction of edemaassociated with softtissue injuries such asburns, postoperativeedema, and ligamentsprains.Decrease the risk ofdeep venous thrombosis(DVT).	The Venodyne DVTAdvantage model620 is designed tocompress the lowerlimbs aiding theblood flow backtoward the heart toprevent deep veinthrombosis inpatients at risk.	The Cowboy XV isintended for patients inthe home who wouldbenefit from increasedblood flow to:Treat and assist healingof cutaneous ulceration(wounds), reduce wouldhealing time, enhancearterial circulation(blood flow), reducecompartmentalpressures, reduceedema (swelling),reduce the need foranticoagulantmedications(medications that thinthe blood), and preventdeep venous thrombosis(DVT) (blood clots indeep veins).
UL Mark	UL 60601 Class II, Type B	UL - Type BF, Class 1	Not Known	UL
CE Mark	IEC 60601-1 (safety)IEC 60601-1-1 (Emissions,Class A)IEC 60601-1-2 (Immunity)	Not Known	Yes	Not Known

of DVT Therany Modality Comparison for the Unit ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Page 7 of 7

Table 4.Summary of DVT BiocomParameter	VascuTherm air-onlytherapy wraps for DVTprevention only	Aircast Vena Flow SterileDisposable Cuffs(K023800)
Material in Skin Contact	DuPont Softesse® MedicalFabric (non-latex, non-woven)	DuPont Softesse® MedicalFabric (non-latex, non-woven)
Sterile/Non-Sterile	Non-Sterile	Non-Sterile and Sterile
Single Patient Use	Yes	Yes

of DVT Biocompatibility Comparison for the Wraps

Table 5. Summary of Water Circulating Thermal Therapy

Parameter	NanoTherm andVascuTherm devices	Artrotherm Cryotherapy andThermotherapy (K964799)
Therapy Type	Heat/Cool	Heat/Cool
Therapy Temperature Range	Heat: 105°FCold: 43°F to 49°F	Heat: 122°FCold: 43°F
Indications for Use	Localized thermal therapy (hot orcold) for post traumatic and postsurgical medical and/or surgicalconditions. (K964799)	Localized thermal therapy (hot orcold) for post traumatic and postsurgical medical and/or surgicalconditions.

{7}------------------------------------------------

Image /page/7/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The seal is presented in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2006

ThermoTek, Inc. C/O Mr. Jay Kogoma Senior Staff Engineer 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087

Re: K061866

K061866
Trade/Device Name: NanoTherm and VascuTherm Systems
Trade/Device Name: Name 200 Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW, ILO Dated: August 4, 2006 Received: August 7, 2006

Dear Mr. Kogoma:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section 5 IQ(k) premium in enwivelst (for the indications
referenced above and have device is substantialy equivalent (for the indications referenced above and have determined the usevices marketed in interstate
for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally market predical Device America Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Fedical Food, Drug, commerce prior to May 28, 1976, the enactment with the provisions of the Federal Food, Drug,
devices that have been reclassified in accordance with the provisions of the Fede devices that have been reclassified in accordance with the provisions of the Possion (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act. T and Cosmetic Act (Act) that do not require approval or a picularios approvisions of the Act. The
You may, therefore, market the simply do recurements for annual registratio You may, therefore, market the Act include requirements for annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act include requirements to: Michile of Groups of the adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) nito either cities in especial estable on the line can
may be subject to such additional controls. Existing major regulations affect may be subject to such additional controls. EXSthig inajor regalitation and more of the may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898, In and be found in the Code of Federal Regulations, Title BT, Care of Federal Register.
publish further announcements concerning your device in the Federal Register.

{8}------------------------------------------------

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. vichner

Image /page/8/Picture/4 description: The image contains a handwritten symbol that appears to be a combination of curved and angular lines. The symbol is black and stands out against a white background. It is positioned on the left side of the image. The symbol is next to the letters 'E' and 'D'.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _K061866

Device Name: NanoTherm________________________________________________________________________________________________________________________________________________________

Indications for Use:

Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use
(21 CFR 801 Subpart C)

Device Name: VascuTherm ______________________________________________________________________________________________________________________________________________________
Indications for Use:
Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema and chronic lymphedema.
Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
Localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions.
Decrease the risk of deep venous thrombosis (DVT).

Aids the blood flow back to the heart.

Treat and assist healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

mountine of CDRH, Office of Device Evaluation (ODE) Division Sign-Off)

Division of Cardiovascular Devices

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510(k) Number. K061866

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).