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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Tzoar 207 Negative Pressure Wound Therapy (NPWT) System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies directly, especially for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria for AI models, study design, expert ground truth, and specific performance metrics for AI will not be present in this document.

The document mainly covers the technological characteristics, performance tests of the device's physical functions, biocompatibility, and electrical safety.

Here's an analysis based on the available information:

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

The document does not explicitly state "acceptance criteria" in the context of an overall device performance metric that would be suitable for an AI/ML device. Instead, it lists several performance tests conducted on the physical device components. The conclusion drawn from these tests is that the device is "performing as intended" and is "substantially equivalent to the predicate."

Here's a table summarizing the tests mentioned and the general conclusion:

Test Report No.	Test Report Title	Acceptance Criteria (Explicitly Stated)	Reported Device Performance
TR27.0006	Tzoar 207 NPWT Canister Presence Sensor Test Report	Not explicitly stated	Performing as intended
TR27.0007	Tzoar 207 NPWT Canister Hook Test	Not explicitly stated	Performing as intended
TR27.0008	Tzoar 207 NPWT Canister Air-Tightness Test	Not explicitly stated	Performing as intended
TR27.0010	Tzoar207 NPWT Canister Air filter water resistance verification Test	Not explicitly stated	Performing as intended
TR27.0011	Tzoar 207 NPWT Canister Solidifier Expansion Parameter Test Report	Not explicitly stated	Performing as intended
TR27.0013	Tzoar 207 NPWT System Pressure Accuracy Test Report	Not explicitly stated	Performing as intended
TR27.0014	Tzoar 207 NPWT System Air Flow Rate Test	Not explicitly stated	Performing as intended
TR27.0025	Tzoar 207 NPWT System performance test with One Piece Dressing Test	Not explicitly stated	Performing as intended
TR27.0027	Tzoar 207 NPWT System Performance test with Foam Kit	Not explicitly stated	Performing as intended
TR27.0032	Tzoar 207 NPWT System Battery Life Test Report	Not explicitly stated	Performing as intended
TR27.0033	Tzoar 207 NPWT System Battery Performance Testing Report	Not explicitly stated	Performing as intended
Biocompatibility	ISO 10993-5, -10, -11, -6	Compliance with ISO standards	Met standards
Electrical Safety & EMC	IEC 60601-1, -1-2, -1-6, -1-11	Compliance with IEC standards	Met standards

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

The document does not describe a "test set" in the context of data for an AI/ML device. The "tests" mentioned are for the physical components and functionality of the NPWT system. The sample sizes for these physical performance tests are not specified in this summary document. Data provenance is not applicable as this is a device clearance, not an AI model clearance.

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. This device is a Negative Pressure Wound Therapy system, which is a physical medical device. It does not appear to incorporate AI/ML technology that would require expert-established ground truth on a test set of data.

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

Not applicable, as there is no mention of a test set requiring adjudication for AI/ML performance.

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 wound therapy system and does not involve human "readers" or AI assistance in interpretation.

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

Not applicable, as this is a physical medical device, not an algorithm or AI.

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

Not applicable. The "ground truth" for this device would be its ability to perform its stated functions (e.g., maintain pressure, seal, battery life) according to engineering specifications and relevant standards. This is assessed through physical performance tests, not through expert review of data or pathology.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model.

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

Not applicable. This is a physical medical device, not an AI/ML model.

Summary

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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

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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)

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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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,

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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 resistanceverification Test
TR27.0011	Tzoar 207 NPWT Canister Solidifier Expansion ParameterTest 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 PieceDressing 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 TestingReport

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

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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.

Regulation Number and Section

§ 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.