(87 days)
The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
The product has 2 sizes: 50mm(L)×50mm(W)×5mm(T) and 50mm(L)×25mm(W)× 5mm(T). The product is composed by a small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel' with a polyurethane foam base and pressure sensitive adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.
The provided FDA 510(k) summary (K241022) for the Sterile single use tip cleaner (WK800-S10, WK800-S20) does not contain information on how the acceptance criteria were established or details of a study that proves the device meets specific performance criteria related to clinical efficacy.
The document focuses on non-clinical performance testing for physical characteristics and manufacturing-related residuals, primarily to establish substantial equivalence to a predicate device. There is no mention of clinical studies, human reader performance, AI assistance, or related metrics.
Here's an analysis based on the information provided, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Requirement) | Reported Device Performance (Result) |
|---|---|---|
| Appearance | 1.1 The surface of the product should be clean, free from damage, cracking, or other undesirable phenomena. | PASS |
| 1.2 The product sandpaper surface, sponge base layer, pressure-sensitive adhesive, X-ray ray, and release paper should be tightly bonded, no curling/falling off. | PASS | |
| Product Performance | 2.1 The double-sided adhesive has good adhesion, smoothness, and no warping. | PASS |
| 2.2 There is no sand falling off on the polishing abrasive (sandpaper) surface. | PASS | |
| 2.3 The peel strength of the double-sided adhesive should be ≥ 2N/CM. | PASS | |
| Residual Testing | 3. FTO Residual ≤ 4mg/pcs; ECH ≤ 9mg/pcs. | PASS |
Note: These acceptance criteria are for non-clinical, physical, and manufacturing characteristics, not for clinical performance or diagnostic accuracy.
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 specifies "Non-clinical Performance Testing" but does not provide details on the sample size for these tests (e.g., how many units were tested for peel strength or appearance). It also does not mention the data provenance beyond it being conducted by the manufacturer, WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. in China. Given the nature of these tests, they would be prospective manufacturing quality and material property tests.
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 tests performed are non-clinical, evaluating physical properties and chemical residuals, not requiring expert clinical interpretation or ground truth establishment in the way a diagnostic imaging device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human interpretation or adjudication. The results are from physical measurements and observations against defined specifications.
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
No. This device is a sterile single-use tip cleaner, an accessory for electrosurgical cauterization. It is a physical medical device, not an AI or software-driven diagnostic or assistive tool. Therefore, an MRMC study or AI assistance is not relevant to its regulatory submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. As explained above, this device is not an AI algorithm. The performance tests are for its physical properties and sterility.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests, the "ground truth" or reference is the predefined technical specifications and standards (e.g., "free from damage, cracking," "peel strength ≥ 2N/CM," "FTO Residual ≤ 4mg/pcs"). These are established engineering and quality control criteria.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable, for the same reasons above.
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July 11, 2024
WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd Haobin Li General Manager TangJiao XingWang Street, LiLin Town, ZhongKai Hi-Tech Zone HuiZhou, GuangDong 516003 China
Re: K241022
Trade/Device Name: Sterile single use tip cleaner (WK800-S10 , WK800-S20) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 20, 2024 Received: May 20, 2024
Dear Haobin Li:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Digitally signed by Long H. Chen
Long H. Chen -S -s
Date: 2024.07.11 15:06:45 -04'00'
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Sterile single use tip cleaner (WK800-S10 , WK800-S20)
Indications for Use (Describe)
The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
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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K241022
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. 510(K) SUMMARY
This summary of 510(K) is being submitted in accordance with the requirements of 21 CFR 8807.92.
Type of submission :Traditional The assigned 510(K) number is:K241022 The date the summary was prepared: April 15, 2024
1. Submitter information:
Manufacturer Name: WickiMed(Huizhou) Medical Equipment Manufacturing Co.,Ltd.
Address: TangJiao Street, LiLin Town, ZhongKai XingWang -Hi-Tech Zone, HuiZhou,GuangDong, China.
Establishment Registration Number:3010601992
Contact person:Haobin Li
Position: General Manager
Tel : 0086-0752-3860807
Fax : 0086-0752-3863017
E-mail: mac lai@wickimed.com
2. Device Information:
Trade/Common Name: Sterile single use tip cleaner Models: WK800-S10 ,WK800-S20 Regulatory Class: Class II Regulatory Number: 21 CFR 878.4400 Review Panel: General & Plastic Surgery Product Code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
3. Predicative Device
Manufacturer: Key Surgical Incorporated Trade/Device Name: Key Surgical® Cautery Tip Cleaner Product Code: GEI 510(k) Number: K151222
4. Indication for Use
The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical
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K241022
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd. cauterization blades during surgical procedures.
5. Device Description
The product has 2 sizes: 50mm(L)×50mm(W)×5mm(T) and 50mm(L)×25mm(W)×
5mm(T). The product is composed by a small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel' with a polyurethane foam base and pressure sensitive adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.
6. Comparison of Intended Use and Technological Characteristics
The Sterile single use tip cleaner predicate device is the Key Surgical, Inc., K151222, cleared on May 22, 2015. The following illustrates the similarities in the product design.
| Characteristics | Predicate Device | Proposed Device |
|---|---|---|
| Key Surgical®Cautery Tip CleanerK151222 | Sterile single use tip cleaner | |
| Indications for Use | The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures. | The sterile single use tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures. |
| Conditions of Use | Single Use, disposable | Single Use, disposable |
| Materials | Aluminum oxide 'gravel', with a polyurethane foam pad and polyurethane adhesive layer containing a barium monofilament for x-ray detection. | Aluminum oxide 'gravel' with a polyurethane foam base and pressure sensitive adhesive layer containing a barium monofilament for x-ray detection. |
| Adhesive back | Yes, for universal placement and aid in keeping the device in place. | Yes, for universal placement and aid in keeping the device in place. |
| Sterility | Provided Sterile | Provided Sterile |
| Principle of Operation | The cautery tip cleaner is used | The cautery tip cleaner is used |
Table 1 : Comparison to Predicate device
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K241022
| to aid in the removal of escharon electrosurgical bladesduring surgical procedures. | to aid in the removal of escharon electrosurgical bladesduring surgical procedures. | |
|---|---|---|
| Interface with ElectrosurgicalCauterization Blade | The Cautery Tip Cleaner doesnot impact the function of theelectrosurgical cauterizationblades. It is not required foruse with the blades, but anaccessory that aids in theremoval of eschar buildup. | The sterile single use tipcleaner does not impact thefunction of the electrosurgicalcauterization blades. It is notrequired for use with theblades, but an accessory thataids in the removal of escharbuildup. |
WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
7. Summary of Non-clinical Performance Testing
| Item | Requirement | Result |
|---|---|---|
| 1. Appearance | 1.1The surface of the product should be clean, free from damage, cracking, or other undesirable phenomena. | PASS |
| 1.2 The product sandpaper surface, sponge base layer, pressure-sensitive adhesive, X-ray ray, and release paper should be tightly bonded together, and there should be no curling or falling off. | PASS | |
| 2.Product performance | 2.1 The double-sided adhesive has good adhesion, smoothness and no warping. | PASS |
| 2.2 There is no sand falling off on the polishing abrasive (sandpaper) surface. | PASS | |
| 2.3 The peel strength of the double-sided adhesive should be≥2N/CM. | PASS | |
| 3. Residual Testing | 3. FTO Residual ≤4mg/pcs ECH≤9mg/pcs | PASS |
| Table 2 : Non-clinical Performance Testing | |||
|---|---|---|---|
| -- | -- | -------------------------------------------- | -- |
8. Conclusion
The sterile single use tip cleaner is as safe and effective as the predicate device.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.