(457 days)
Not Found
No
The summary describes a standard negative pressure wound therapy system with a pump and dressings, and the performance studies focus on mechanical and functional aspects of the device, with no mention of AI or ML.
Yes
The device is indicated for wound management and promotes wound healing by applying negative pressure and removing exudates, which are therapeutic actions.
No
The device is described as a wound management system that applies negative pressure to wounds to remove exudate and debris, promoting healing. It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly states that the system includes a "pump" and "dressings," which are hardware components. The performance studies also detail testing of physical aspects like "canister presence sensor," "battery life," and "mechanical testing."
Based on the provided information, the Tzoar Negative Pressure Wound Therapy (NPWT) System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for wound management by applying negative pressure to remove exudate, infectious materials, and tissue debris directly from the wound bed. This is a therapeutic intervention applied to the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device consists of a pump and dressings used to apply negative pressure to a wound. This aligns with a therapeutic device, not a device used for analyzing biological samples.
- No mention of in vitro testing: The description does not mention any components or processes related to testing biological samples (like blood, urine, tissue) in a laboratory setting.
- Performance Studies: The performance studies described focus on the mechanical and functional performance of the device in applying negative pressure and managing wound exudate, not on the accuracy or reliability of diagnostic measurements.
In summary, the Tzoar NPWT System is a therapeutic device used for wound treatment, not a diagnostic device used for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
The Tzoar Negative Pressure Wound Therapy (NPWT) System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Product codes (comma separated list FDA assigned to the subject device)
OMP
Device Description
The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System includes a pump and two types of dressings: Tzoar NPWT Foam Kits and Tzoar NPWT One Piece Dressing.
The Tzoar 207 NPWT pump is a portable, battery powered pump which may promote wound healing through the drainage and removal of wound exudates, infectious material, and tissue debris from the wound bed using continuous and/or intermittent negative pressure.
The Tzoar NPWT One Piece Dressing and the Tzoar NPWT Foam Kits are both Tzoar Wound Dressings intended to be used with an NPWT device to manage acute and chronic wounds. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, neuropathic ulcers, pressure ulcers, flaps and grafts may benefit from this system.
The Tzoar 207 NPWT pump and Tzoar Wound Dressings are able to produce a negative pressure environment in either Continuous or Intermittent Mode. This allows the user to program the specific pressure ranges. In Continuous Mode, the pressure is ranged from 40mmHg to 200mmHg. In Intermittent Mode, the pump will alternate between the up pressure for 5 continuous minutes and down pressure for 2 minutes. The up pressure can be selected between 40 and 200mmHg while the down pressure can be selected between 20 and 120 mmHg. The pressure is applied to the wound as long as the pump is powered on the previous settings. The factory default is 125 mmHg in Continuous Mode, unlocked.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To verify that the device design meet its function and performance requirements, samples of the device underwent function and mechanical testing.
| Test Report No. | Test Report Title |
|---|---|
| TR27.0006 | Tzoar 207 NPWT Canister Presence Sensor Test Report |
| TR27.0007 | Tzoar 207 NPWT Canister Hook Test |
| TR27.0008 | Tzoar 207 NPWT Canister Air-Tightness Test |
| TR27.0010 | Tzoar207 NPWT Canister Air filter water resistance verification Test |
| TR27.0011 | Tzoar 207 NPWT Canister Solidifier Expansion Parameter Test Report |
| TR27.0013 | Tzoar 207 NPWT System Pressure Accuracy Test Report |
| TR27.0014 | Tzoar 207 NPWT System Air Flow Rate Test |
| TR27.0025 | Tzoar 207 NPWT System performance test with One Piece Dressing Test |
| TR27.0027 | Tzoar 207 NPWT System Performance test with Foam Kit |
| TR27.0032 | Tzoar 207 NPWT System Battery Life Test Report |
| TR27.0033 | Tzoar 207 NPWT System Battery Performance Testing Report |
The conclusions drawn from the performance tests demonstrate that the device is performing as intended and is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
December 30, 2021
Lightstone Medical Products (Ningbo) Co Ltd % Ruth Wu Consultant Lightstone Medical 1820 Ave M, Ste 238 Brooklyn, New York 11230
Re: K202898
Trade/Device Name: Tzoar 207 Negative Pressure Wound Therapy (NPWT) System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: OMP Dated: September 25, 2021 Received: November 19, 2021
Dear Ruth Wu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
Tzoar 207 Negative Pressure Wound Therapy (NPWT) System
Indications for Use (Describe)
The Tzoar Negative Pressure Wound Therapy (NPWT) System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Submitter:
Lightstone Medical Products (Ningbo) Co Ltd. Room 61-408, No. 99, Jiangbei Road, Ningbo, Zhejiang, China 315032 Phone: +86 574 56579003 Contact Person: Julian Zhu Date Prepared: September 24, 2020
Device:
| Common Names: | Negative Pressure Wound Therapy Device |
|---|---|
| Proprietary Name: | Tzoar 207 Negative Pressure Wound Therapy (NPWT) System |
| Regulation Number: | 21 CFR 878.4780 |
| Classification Name: | Negative Pressure Wound Therapy Powered Suction Pump |
| Regulatory Class: | II |
| Product Code: | OMP |
Predicate Devices:
The Tzoar 207 Negative Pressure Wound Therapy System is substantially equivalent to the following:
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| extriCARE 3600 | Devon Medical | K132225 |
Device Description
The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System includes a pump and two types of dressings: Tzoar NPWT Foam Kits and Tzoar NPWT One Piece Dressing.
The Tzoar 207 NPWT pump is a portable, battery powered pump which may promote wound healing through the drainage and removal of wound exudates,
4
infectious material, and tissue debris from the wound bed using continuous and/or intermittent negative pressure.
The Tzoar NPWT One Piece Dressing and the Tzoar NPWT Foam Kits are both Tzoar Wound Dressings intended to be used with an NPWT device to manage acute and chronic wounds. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, neuropathic ulcers, pressure ulcers, flaps and grafts may benefit from this system.
The Tzoar 207 NPWT pump and Tzoar Wound Dressings are able to produce a negative pressure environment in either Continuous or Intermittent Mode. This allows the user to program the specific pressure ranges. In Continuous Mode, the pressure is ranged from 40mmHg to 200mmHg. In Intermittent Mode, the pump will alternate between the up pressure for 5 continuous minutes and down pressure for 2 minutes. The up pressure can be selected between 40 and 200mmHg while the down pressure can be selected between 20 and 120 mmHg. The pressure is applied to the wound as long as the pump is powered on the previous settings. The factory default is 125 mmHg in Continuous Mode, unlocked.
Indication for Use:
The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is indicated for wound management via the application of negative pressure to the wound by the removal of wound exudate, infectious materials, and tissue debris from the wound bed. The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is indicated for the following wound types: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
Contraindications:
The Tzoar 207 NPWT System should NOT be used in the following conditions:
- . Exposed vessels, organs, or nerves.
- Anastomotic sites.
- Exposed arteries or veins in a wound. ●
- Fistulas, unexplored or non-enteric.
- Untreated osteomyelitis.
- Malignancy in the wound.
- Excess amount of necrotic tissue with eschar.
- Wounds which are too large or too deep to be accommodated by the dressing. ●
- Allergy to urethane dressings and adhesives.
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- Use of topical products which must be applied more frequently than the dressing change . schedule allows.
Technological Characteristics:
The manufacturer believes that the technological characteristics of the Tzoar 207 Negative Pressure Wound Therapy (NPWT) System are substantially equivalent to those of the predicate device. The Tzoar 207 NPWT System has similar components to its predicate device and has similar principles of operation.
The Tzoar 207 NPWT Pump consists of an electrically generated source of vacuum and a canister. Like the predicate, vacuum, is applied for a specified period of time and intensity, according to the physician's prescription.
Both Tzoar NPWT Foam Kits and Tzoar NPWT One Piece Dressings are alternatively used together with the Tzoar 207 NPWT pumps. The Tzoar NPWT Foam Kits and Tzoar NPWT One Piece Dressings use similar components and similar principles of operation to the predicate device. Like the predicate, the foam is placed into the wound and attached to a vacuum device to provide negative pressure to the wound site to promote healing by removing wound exudates.
Performance Tests
To verify that the device design meet its function and performance requirements, samples of the device underwent function and mechanical testing.
| Test Report No. | Test Report Title |
|---|---|
| TR27.0006 | Tzoar 207 NPWT Canister Presence Sensor Test Report |
| TR27.0007 | Tzoar 207 NPWT Canister Hook Test |
| TR27.0008 | Tzoar 207 NPWT Canister Air-Tightness Test |
| TR27.0010 | Tzoar207 NPWT Canister Air filter water resistance |
| verification Test | |
| TR27.0011 | Tzoar 207 NPWT Canister Solidifier Expansion Parameter |
| Test Report |
The following tests were conducted:
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| TR27.0013 | Tzoar 207 NPWT System Pressure Accuracy Test Report |
|---|---|
| TR27.0014 | Tzoar 207 NPWT System Air Flow Rate Test |
| TR27.0025 | Tzoar 207 NPWT System performance test with One Piece |
| Dressing Test | |
| TR27.0027 | Tzoar 207 NPWT System Performance test with Foam Kit |
| TR27.0032 | Tzoar 207 NPWT System Battery Life Test Report |
| TR27.0033 | Tzoar 207 NPWT System Battery Performance Testing |
| Report |
The conclusions drawn from the performance tests demonstrate that the device is performing as intended and is substantially equivalent to the predicate.
Biocompatibility
Biocompatibility tests were conducted according to the following standards:
- . ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
- . ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- . ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- . ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC tests were conducted according to the following standards:
- o IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012(or IEC 60601-1:2012 reprint) Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
7
- IEC 60601-1-6:2010+A1:2013 Medical Electrical Equipment –Part 1-6 General Requirements . for Basic Safety and Essential Performance -Collateral Standard: Usability
- IEC 60601-1-11:2015 Medical Electrical Equipment -Part 1-11 General Requirements for ● Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems used in the Home Healthcare Environment
Statement of Substantial Equivalence
The Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is substantially equivalent in technology, function, operating parameters, and indication for use to the predicate device that is currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Lightstone Medical Products (Ningbo) Co Ltd believes that the Tzoar 207 Negative Pressure Wound Therapy (NPWT) System is substantially equivalent to the predicate device extriCARE 3600 (K132225) as described herein.