(148 days)
Modpod cervical traction provides mobilization of skeletal structures and muscles in static, intermittent, progressive, and regressive distraction forces to relieve pressures that may be causing pain of skeletal or muscular origin. These effects are achieved through decompression of intervertebral discs, that is, unloading due to distraction and positioning, and may be used to relieve peripheral radiation/sciatica and pain associated with:
• Protruding discs
• Bulging discs
• Herniated discs
• Degenerative disc disease
• Posterior facet syndrome
• Acute facet problems
• Radicular pain
• Prolapsed discs
• Spinal root impingement
• Hypomobility
• Degenerative joint disease
• Facet syndrome
• Compressions fracture
• Joint pain
• Discogenic pain
The Modpod™ Cervical Traction Device provides static and intermittent distraction forces to the cervical spine to relieve pressures on structures that may be causing pain of skeletal or muscular origin. Therapeutic distraction can be applied in a variety of programmable patterns and functions.
The device design allows a clinician access to a patients head and neck when hands-on interaction and positioning is needed. Use of the device reduces the level of exertion experienced by the clinician when compared to manual traction therapy techniques. Additionally, hands-on interaction and positioning by the clinician may occur before or after treatment.
Painted sheet metal and ABS plastic encasement housing electronic circuitry; software and electronics engage a gear driven motor with load sensors; slide mechanism, and patient head harness to apply cervical traction.
I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a 510(k) premarket notification letter from the FDA to Hollywog, LLC, regarding their device called "Modpod".
This document primarily focuses on establishing substantial equivalence to previously marketed predicate devices (K051938 and K053223). It details:
- Indications for Use: The medical conditions the device is intended to treat.
- Technical Specifications: Information about the device's design, power supply, components, and operational characteristics.
- Comparison to Predicate Devices: A comprehensive table comparing the Modpod to the predicate devices across various parameters like regulation, product class, intended use, anatomical site, maximum traction force, electrical standards, etc.
However, the document does not contain information about specific acceptance criteria (performance metrics) or a study report with associated data and statistical analysis that proves the device meets such criteria. It states that "The Modpod cervical traction device is as safe and effective, and performs as well or better than the claimed predicate devices," which is a conclusion based on the comparison provided, but not a detailed study report with results against predefined acceptance criteria.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- How training set ground truth was established.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust 13, 2015
Hollywog, LLC Michael Treas Chief Compliance Officer 2830 Ammicola Highway Chattanooga, Tennessee 37377
Re: K150695
Trade/Device Name: Modpod Regulation Number: 21 CFR 890.5900 Regulation Name: Power Traction Equipment Regulatory Class: Class II Product Code: ITH Dated: July 9, 2015 Received: July 10, 2015
Dear Mr. Treas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -SFD/^
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150695
Device Name Modpod
Indications for Use (Describe)
Modpod cervical traction provides mobilization of skeletal structures and muscles in static, intermittent, progressive, and regressive distraction forces to relieve pressures that may be causing pain of skeletal or muscular origin. These effects are achieved through decompression of intervertebral discs, that is, unloading due to distraction and positioning, and may be used to relieve peripheral radiation/sciatica and pain associated with:
·Protruding discs
·Bulging discs
- ·Herniated discs
·Degenerative disc disease
·Posterior facet syndrome
· Acute facet problems
•Radicular pain
·Prolapsed discs
- ·Spinal root impingement
·Hypomobility
·Degenerative joint disease
·Facet syndrome
·Compressions fracture
•Joint pain
· Discogenic pain
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image is a logo for Hollywog. The logo is a blue square with the word "Hollywog" in white text at the top. Below the text is a green frog. The frog is facing to the right.
ES
A leap forward™
Holluwoa 830 Amnicola Highway nattanooga, TN 37406 USA +1423 305 7778 +1 423 305 7867 holluwoa.com
510(k) Summary per 21 CFR; 807.92 510(k) K150695
| 510(k) SUBMITTER: | Hollywog, LLC |
|---|---|
| ESTABLISHMENT REGISTRATION: | 3008585473 |
| CONTACT: | Michael W. TreasChief Compliance OfficerTelephone (423) 305-7778Fax (423) 305-7867 |
| DATE PREPARED: | July 9, 2015 |
| PROPRIETARY NAME: | ModpodTM |
| PANEL: | Physical Medicine |
| REGULATION NUMBER: | CFR Title 21, 890.5900 |
| CLASSIFICATION: | Class II |
| PRODUCT CODE: | ITH |
| REGULATION DESCRIPTION: | Power traction equipment |
| COMMON NAME: | Cervical traction |
The Modpod™ Cervical Traction Device provides static and intermittent distraction forces to the cervical spine to relieve pressures on structures that may be causing pain of skeletal or muscular origin. Therapeutic distraction can be applied in a variety of programmable patterns and functions.
The device design allows a clinician access to a patients head and neck when hands-on interaction and positioning is needed. Use of the device reduces the level of exertion experienced by the clinician when compared to manual traction therapy techniques. Additionally, hands-on interaction and positioning by the clinician may occur before or after treatment.
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| 510(k) # | Predicate Proprietary Trade Name | Predicate Regulation |
|---|---|---|
| K051938 | Triton®/Tru-Trac®/TX™ Traction | CFR Title 21, Sec. 890.5900, Class II, ITH |
| K053223 | Triton®/Tru-Trac®/TX™ Traction | CFR Title 21, Sec. 890.5900, Class II, ITH |
Legally marketed devices to which substantial equivalence is claimed:
The indications for use are substantially equivalent to the claimed predicate devices. Differences between indications for use do not affect safety or effectiveness when used as labeled and as intended. The intended patient population is adults of all ages.
The power supply is an off-the-shelf wall plug type that complies with the IEC 60601-1:2005 Ed.3 standard. The power supply steps down mains voltage to 12VDC and solely serves to charge the lithium ion batteries. The device operates exclusively from the batteries whether the power supply/battery charger is used or not used. The power supply/battery charger automatically switches 100-240VAC +/- 10%; 47-63Hz; 1 Phase; Current 0.9A @ 100VAC to accommodate most electric power service systems worldwide.
If the device is plugged into mains power and not in use the battery is constantly trickle charged. If the device is being used while plugged into mains power the electronic design allows any unused energy from mains power to charge the batteries. The device uses a charging IC to control and regulate charging of the batteries to ensure the batteries do not overcharge. If the device is operating solely on battery power (not plugged into mains power) no charging occurs. The battery voltage is monitored and the battery life status is displayed on the screen. Once the voltage is discharged to near the minimum voltage needed to run the charging IC; the device display screen shows an error and uses an audible tone to alert the clinician the battery needs to be plugged into mains power for charging.
A clinician interfaces with the device through a touch display screen. The electronics and software control the actuator. The device includes an electronic load cell calibrated during the manufacturing process. Subsequent calibration is not be required because the electronics tare/set the load cell to zero each time the device is turned on. Traction forces are administered by an electromechanical linear actuator with a brush-type DC motor. The device is intended for therapeutic care on an outpatient basis. Monitoring technology maintains the set traction force if a patient were to shift or move during a treatment. The actuator has the capability to operate at 12 Volts; the design requires only 4 volts to achieve the desired speed and to lessen the operating noise level. The design uses plastic gears in the actuator to reduce noise. There is no additional voltage generated above that of the batteries, and no components are operated outside their specified ratings. Additionally, the actuator has an internal encasement plus the device encases the actuator. Therefore, the plastic actuator gears are double encased for a high degree of noise reduction. Sound measured during operation of the device measured in the proximity of a patient's ear ranged from 26db to 56db when the actuator is in operation; to virtually no observable sound when the actuator reaches the treatment set point.
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The treatment should only be administered under the presence of a doctor or therapist. The doctor or therapist should be present at all times and supervise the treatment carefully. Never leave the patient alone during the treatment. Use care on patients who do not tolerate supine positions, as they may not be good candidates for traction therapy. There are two types of head harnesses. One head harness has a chin strap; the other does not have a chin strap. The head harness without a chin strap may be chosen by a clinician for their patients who experience discomfort related to pressure sensitivity related to Temporomandibular joint dysfunction (TMJ).
The head halter comes in Cotton Duct Fabric and PVC Coated Polyester Fabric both with Velcro@ adjustment for ease of patient setup in the device cushions are made of I-Skin Polyurethane. The cushion set consists of a Shoulder Support Cushion and Head Support Cushions in 10°, 15° and 20°.
Conclusion:
The Modpod cervical traction device is as safe and effective, and performs as well or better than the claimed predicate devices.
Technical Comparison Attached -
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| 510(k) | K150695 | K051938 | K053223 |
|---|---|---|---|
| Regulation Number | 890.5900 | 890.5900 | 890.5900 |
| Product Class | Class II | Class II | Class II |
| Product Code | ITH | ITH | ITH |
| Intended environment of use | Outpatient clinic | Outpatient clinic | Outpatient clinic |
| Indications for use | Indications for useModpod cervical traction provides mobilization of skeletalstructures and muscles in static, intermittent, progressive, andregressive distraction forces to relieve pressures that may becausing pain of skeletal or muscular origin. These effects areachieved through decompression of intervertebral discs, that is,unloading due to distraction and positioning, and may be usedto relieve peripheral radiation/sciatica and pain associatedwith:• Protruding discs• Bulging discs• Herniated discs• Degenerative disc disease• Posterior facet syndrome• Acute facet problems• Radicular pain• Prolapsed discs• Spinal root impingement• Hypomobility• Degenerative joint disease• Facet syndrome• Compressions fracture• Joint pain• Discogenic pain | Indications for useThe Triton/Tru-Trac/TX traction devices provide traction andmobilization of skeletal structures and skeletal muscles.The Triton/Tru-Trac/TX traction devices provide a treatmentin static, intermittent, progressive, regressive and cyclingdistraction forces to relieve pressures on structures that may becausing pain of skeletal or muscular origin (cervical, thoracic,lumbar, hip, wrist, shoulder). Therapeutic distraction can beapplied in a variety of programmablepatterns, cycles and functions.The Triton/Tru-Trac/TX traction devices may be used torelieve peripheral radiation/sciatica and pain associated with:• Protruding discs• Bulging discs• Herniated discs• Degenerative disc disease• Posterior facet syndrome• Acute facet problems• Radicular pain• Prolapsed discs• Spinal root impingement• Hypomobility• Degenerative joint disease• Facet syndrome• Compressions fractures• Joint pain• Discogenic painThe Triton/Tru-Trac/TX traction devices achieve these effectsthrough decompression ofintervertebral discs, that is, unloading due to distraction andpositioning. | Indications for useThe Triton/ Tru-Trac/TX/Triton DTS Traction devices providetraction and mobilization of skeletal structures and skeletalmuscles.The Triton/ Tru-Trac/TX/Triton DTS Traction devices providea treatment in static, intermittent, progressive, regressive andcycling distraction forces to relieve pressures on structures thatmay be causing pain of skeletal or muscular origin (cervical,thoracic,lumbar, hip, wrist, shoulder). Therapeutic distraction can beapplied in a variety of programmable patterns., cycles andfunctions.The Triton/ Tru-Trac/ TX/ Triton DTS "Traction devices withthe optional EMG (a.k.a. sEMG) biofeedback feature may beused to relieve peripheral radiation/sciaticaand pain associated with:• Protruding discs• Bulging discs• Herniated discs• Degenerative disc disease• Posterior facet syndrome• Acute facet problems• Radicular pain• Prolapsed discs• Spinal root impingement• Hypomobility• Degenerative joint disease• Facet syndrome• Compressions fractures• Joint pain• Discogenic painEMG (a.k.a. sEMG)Determination of the activation magnitude and timing ofmuscles for:a) retraining of muscle activationb)coordination of muscle activation- Determination of the force produced by muscle for controland maintenance of muscle contractions. |
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| - Relaxation muscle training. | |||
|---|---|---|---|
| -Muscle re-education | |||
| Intended Use | Decompression of intervertebral discs of the cervical spine. | Decompression of intervertebral discs of the cervical spine.Alternative uses for decompression of intervertebral discs ofthe thoracic or lumbar. | Decompression of intervertebral discs of the cervical spine.Alternative uses for decompression of intervertebral discs ofthe thoracic or lumbar. |
| Target Population | The intended patient population is adults of all ages. | The intended patient population is adults of all ages. | The intended patient population is adults of all ages. |
| Anatomical Site | Cervical spine | Cervical spine. Alternative uses for other anatomical sites. | Cervical spine. Alternative uses for other anatomical sites. |
| Maximum cervical tractiontension force i.e., energydelivered | 40 pounds | 40 pounds | 40 pounds |
| Human Factors | Rotating display screen for clinician ease for viewing | Rotating display screen for clinician ease for viewing | Rotating display screen for clinician ease for viewing |
| Design | Painted sheet metal and ABS plastic encasement housingelectronic circuitry; software and electronics engage a geardriven motor with load sensors; slide mechanism, and patienthead harness to apply cervical traction. | ABS plastic encasement housing electronic circuitry; softwareand electronics engage a gear driven motor with load sensors;rope mechanism, and patient head mechanism to apply cervicaltraction. | ABS plastic encasement housing electronic circuitry; softwareand electronics engage a gear driven motor with load sensors;rope mechanism, and patient head mechanism to apply cervicaltraction. |
| Electrical medical standards | AAMI/ANSI/ES 60601-1: 2005 Ed. 3/ IEC60601-1:2005 Ed.3 | IEC60601-1:1988 Ed. 2 | IEC60601-1:1988 Ed. 2 |
| meet | (FDA, Standard Recognition #19-5) | (FDA, Standard Recognition #5-4) | (FDA, Standard Recognition #5-4) |
| Electromagnetic compatibilityi.e., compatibility with theenvironment and other devices | AAMI/ANSI/IEC 60601-1-2 :2007 Ed. 3 (FDA, StandardRecognition #19-2) | IEC 60601-1-2:2001 Ed.2(FDA Standard Recognition #5-28) | IEC 60601-1-2:2001 Ed.2(FDA Standard Recognition #5-28) |
| Preset protocols - | Yes | Yes | Yes |
| Protocol name: | Cervical TX | Disc Involvement with muscle guarding | Disc Involvement with muscle guarding |
| Protocol Speed (%): | 30 | 30 | 30 |
| Protocol total time (Min): | 17 | 17 | 17 |
| Progressive Stage - Traction | Static | Static | Static |
| type: | 6 | 6 | 6 |
| Steps: | 10 | 10 | 10 |
| Hold (Sec):Rest (Sec): | 0 | 0 | 0 |
| Traction Stage - Traction type: | Intermittent | Intermittent | Intermittent |
| Steps: | 0 | 0 | 0 |
| Hold (Sec): | 60 | 60 | 60 |
| Rest (Sec): | 20 | 20 | 20 |
| Time (Min): | 15 | 15 | 15 |
| Regressive Stage - Traction | Static | Static | Static |
| type: | 6 | 6 | 6 |
| Steps: | 10 | 10 | 10 |
| Hold (Sec):Rest (Sec): | 0 | 0 | 0 |
| Power source | Automatic switchable power supply 100-240VAC, 50/60Hz+/- 10% tolerance - charging a Lithium Ion Battery, 3.2V-3200mAh | Automatic switchable power supply 100-240VAC, 50/60Hz+/- 10% tolerance | Automatic switchable power supply 100-240VAC, 50/60Hz+/- 10% tolerance |
| Mechanical Safety - Tractionforce can be halted and tractiontension released by a patient | Yes | Yes | Yes |
| held stop switch if the patientfeels discomfort during tractiontherapy | |||
| Steps down mains power tooperate internal electronics andcomponents at low voltage | Yes | Yes | |
| Operates from battery source | Yes | No | |
| Battery type | Rechargeable lithium ion 3200mAh | N/A | |
| Software | Yes | Yes | |
| Accessories | Patient head halter without ridged | Patient head halter with ridged bolsters | |
| Weight (lbs., oz.) | 23.8lbs (10.8kg) | 30 lbs (14 kg) | |
| Dimensions (in.) [W x H x D] | 15.5" (39.4cm)(W) x11.0" (27.9cm)(H) x30.3" (76.8cm)(D) | 9.5 in (24 cm) (W) x17.5 in (45 cm)(H) x17.5 in (45 cm)(D) | |
| Enclosure Material andConstruction | ABS plastic with screwsPainted metal with screws | ABS plastic with screwsNo exposed painted metal | |
| Actuation mechanism | The mechanism for actuation begins with a licensed clinicianengaging the device electronic interface to activate the devicesoftware. The software and electronics engage a gear drivenmotor with load sensors; slide mechanism, and patient headharness to apply cervical traction. The load sensor detects theload cell voltage corresponding to the amount of traction forceto a patient. | The mechanism for actuation begins with a licensed clinicianengaging the device electronic interface to activate the devicesoftware. The software and electronics engage a gear drivenmotor with load sensors; rope mechanism, and patient headharness to apply cervical traction. The load sensor detects theload cell voltage corresponding to the amount of traction forceto a patient. | |
| Thermal Safety | Double encased electronics and actuation mechanism | Double encased electronics and actuation mechanism | |
| Noise | <60db maximum | <60db maximum | |
| DC motor parameters | Brush-type DC motorVariable speed by voltageSlower speed produces lower audible sound | Brush-type DC motorVariable speed by voltageSlower speed produces lower audible sound | |
| Sterility | Intended use non-sterile | Intended use non-sterile | |
| Chemical Safety | Intended use does not involve chemicals | Intended use does not involve chemicals | |
| Radiation Safety | Intended use in non-radiation environments | Intended use in non-radiation environments | |
| Biocompatibility | Modpod™ Cushion SetPolyurethane | Tru-Trac® Traction Bolster SetPolyurethane |
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| Yes | |
|---|---|
| No | |
| N/A | |
| Yes | |
| Patient head halter with ridged bolsters | |
| 30 lbs (14 kg) | |
| (24 cm) (W) x | |
| n (45 cm)(H) x | |
| n (45 cm)(D) | |
| plastic with screws | |
| posed painted metal | |
| mechanism for actuation begins with a licensed clinician | |
| ing the device electronic interface to activate the device | |
| are. The software and electronics engage a gear driven | |
| with load sensors; rope mechanism, and patient head | |
| s to apply cervical traction. The load sensor detects the | |
| cell voltage corresponding to the amount of traction force | |
| atient. | |
| le encased electronics and actuation mechanism | |
| maximum | |
| -type DC motor | |
| ble speed by voltage | |
| r speed produces lower audible sound | |
| Intended use non-sterile | |
| Intended use does not involve chemicals | |
| Intended use in non-radiation environments | |
| Trac® Traction Bolster Set | |
| rethane |
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).