RightLance Blood Lancing System

K222034 · Beijing Ruicheng Medical Supplies Co., Ltd. · QRL · Sep 7, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222034
• Device Name: RightLance Blood Lancing System
• Applicant: Beijing Ruicheng Medical Supplies Co., Ltd.
• Product Code: QRL · General, Plastic Surgery
• Decision Date: Sep 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2

Intended Use

The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. This system is for use only on a single patient in a home setting. This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Device Story

RightLance Blood Lancing System consists of a reusable spring-driven lancing device and sterile, single-use disposable lancets. Device collects capillary blood samples for diagnostic testing. User inserts lancet, primes device via button, and triggers firing mechanism to puncture skin at adjustable depths. Lancet retracts automatically after firing; ejector sleeve allows contactless disposal. Intended for home use by single patient. Benefits include hygienic, controlled blood sampling for glucose or other diagnostic monitoring. Device is manually operated; no electronic or software components.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993-4, -5, -10, -11), sterilization validation (ISO 11137-2), pyrogenicity (USP34<151>), and performance testing (puncture depth, firing force, drop testing, and shelf-life aging).

Technological Characteristics

Mechanical spring-driven lancing device. Lancets are stainless steel, beveled with 3 facets, available in 21G-33G. Depth adjustment via cap (0.1mm-2.2mm range depending on model). Sterilization via gamma irradiation. No energy source other than mechanical spring. No software or connectivity.

Indications for Use

Indicated for hygienic collection of capillary blood for testing from fingertip, palm, upper arm, or forearm. For single-patient home use only. Not for multi-patient healthcare settings.

Regulatory Classification

Identification

The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Special Controls

*Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (b) *Single use only blood lancet without an integral sharps injury prevention feature* —(1)*Identification.* A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) Handwashing instructions for the user before and after use of the device. (C) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device. (E) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Discard the entire device after use.” (B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.” (c) *Multiple use blood lancet for single patient use only* —(1)*Identification.* A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that: (A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and (B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection. (ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use. (iii) The device must be demonstrated to be biocompatible. (iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin ( *e.g.,* blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected. (vi) Labeling must include: (A) Detailed descriptions, with illustrations, of the proper use of the device. (B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use. (C) Handwashing instructions for the user before and after use of the device. (D) Instructions on preparation ( *e.g.,* cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device. (F) Instructions for the safe disposal of the device. (G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades. (H) Labeling must be appropriate for the intended use environment. ( *1* ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.( *2* ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed: (A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.” (B) “Used lancet blades must be safely discarded after a single use.” (C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.” (d) *Multiple use blood lancet for multiple patient use* —(1)*Identification.* A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2) *Classification.* Class III (premarket approval).(3) *Date PMA or notice of completion of a PDP is required:* A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Accu-Chek Softclix Blood Lancing System (K214022)

Submission Summary (Full Text)

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September 7, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font, also in blue.

Beijing Ruicheng Medical Supplies Co., Ltd. % Mr. Ray Wang General Manager No.13 Yanqi Ave, Yanqi Economic Development Zone, Huairou District, Beijing China, 101400

Re: K222034

Trade/Device Name: RightLance Blood Lancing System Regulation Number: 21 CFR 878.4850 Regulation Name: general & plastic surgery Regulatory Class: Class II Product Code: QRL, QRK Dated: July 7, 2022 Received: July 11, 2022

## Dear Mr. Wang:

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 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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Long Chen, Ph.D. Assistant Director DHT4A: Division of General 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K222034

Device Name RightLance Blood Lancing System

Indications for Use (Describe)

The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

This system is for use only on a single patient in a home setting.

This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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- 1. Date of Preparation: 09/07/2022
- 2. Contact Details [21 CFR 807.92(a)(1)]

Applicant (Sponsor) Name: Beijing Ruicheng Medical Supplies Co., Ltd. Applicant (Sponsor) Address: No.13 Yanqi Ave, Yanqi Economic Development Zone, Huairou District, Beijing China, 101400

Applicant Contact #1: Mr. Ray Wang Tel: [phone] Email: [e-mail]

Applicant Contact #2: Ms. Yuechao Li Tel: [phone] Email: [e-mail]

- Proposed Device Name [21 CFR 807.92(a)(2)] 3. Device Trade Name: RightLance Blood Lancing System. Common Name: Blood Lancet. Classification Name: Blood Lancet. Regulation Name: 878.4850, Class II Product Code: QRL, QRK
- 4. Legally Marketed Predicate Device [21 CFR 807.92(a)(3)] 510(k) Number: K214022 Product Name: Accu-Chek Softclix Blood Lancing System Manufacturer: Roche Diabetes Care, Inc.
- 5. Device Description [21 CFR 807.92(a)(4)]

The proposed device, RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

This system is for use only on a single patient in a home setting.

This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.

The RightLance Blood Lancing System is made up of Lancing Device and Disposable Lancet.

The Model of Lancing Device: RC-AD-III; RC-AD-IIIT; RC-AD-VIU; RC-AD-VIX; RC-AD-VIXT; RC-AD-VII; RC-AD-XI; RC-AD-XII; RC-AD-XIV; Sinodraw; RC-LD-16; RC-LD-17; RC-LD-18; RC-LD-19

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The Model of Disposable Lancet: I Size: 21G, 23G, 25G, 26G, 27G, 28G, 30G, 31G, 32G, 33G

- Indication for Use Statement [21 CFR 807.92(a)(5)] 6.
The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.

The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.

This system is for use only on a single patient in a home setting.

This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting

- 7. Indication for Use Comparison [21 CFR 807.92(a)(5)]
The indications for use of the RightLance Blood Lancing System are the same as the predicate device, the Accu-Chek Softclix Blood Lancing System.

| | Proposed Device K222034 | Predicate Device K214022 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The RightLance Blood Lancing<br>System is intended for the hygienic<br>collection of capillary blood for testing<br>purposes from the side of a fingertip<br>and from alternative sites, such as the<br>palm, the upper arm, and the forearm.<br>The sterile, single-use lancets are to be<br>used with the reusable lancing device<br>that is to be cleaned and disinfected<br>between each use, and then the lancets<br>are to be disposed of.<br>This system is for use only on a single<br>patient in a home setting.<br>This system is not suitable for use by<br>healthcare professionals with multiple<br>patients in a healthcare setting | The Accu-Chek Softclix Blood<br>Lancing System is intended for the<br>hygienic collection of capillary blood<br>for testing<br>purposes from the side of a fingertip<br>and from alternative sites, such as the<br>palm, the upper arm, and the forearm.<br>The sterile, single-use lancets are to<br>be used with the reusable lancing<br>device that is to be cleaned and<br>disinfected<br>between each use, and then the<br>lancets are to be disposed of.<br>This system is for use only on a<br>single patient in a home setting.<br>This system is not suitable for use by<br>healthcare professionals with<br>multiple patients in a healthcare<br>setting |
| | Proposed Device K222034 | Predicate Device K214022 |
| Device description | The Lancing Device uses compatible<br>Disposable Lancet to obtain a drop of<br>blood from a fingertip or alternative<br>sites | The Accu-Chek Softclix Lancing Device<br>uses compatible Accu-Chek Softclix<br>Lancets to obtain a drop of blood from a<br>fingertip or alternative sites using the<br>Accu-Chek Softclix Alternative Site<br>Testing (AST) Cap. |
| Number of<br>Uses | Base (lancing device): multiple use<br>Lancet: single use | Base (lancing device): multiple use<br>Lancet: single use |
| Lancet<br>Sterility | Yes, gamma irradiation | Yes, gamma irradiation |
| Needle | 0.80mm (21G); beveled cut with 3<br>facets<br>0.60mm (23G); beveled cut with 3<br>facets<br>0.50mm (25G); beveled cut with 3<br>facets<br>0.45mm (26G); beveled cut with 3<br>facets<br>0.40mm (27G); beveled cut with 3<br>facets<br>0.37mm (28G); beveled cut with 3<br>facets<br>0.32mm (30G); beveled cut with 3<br>facets<br>0.26mm (31G); beveled cut with 3<br>facets<br>0.23mm (32G); beveled cut with 3<br>facets<br>0.20mm (33G); beveled cut with 3<br>facets | 0.4mm (28G); beveled cut with 3 facets |
| Depth<br>adjustment | RC-AD-III: 6 levels by adjusting<br>cap(0.3mm-1.5mm)<br>RC-AD-IIIT: 6 levels by adjusting<br>cap(0.3mm-1.5mm)<br>RC-AD-VIU: 6 levels by adjusting<br>cap(0.7mm-2.2mm)<br>RC-AD-VIX: 6 levels by adjusting<br>cap(0.3mm-1.5mm) | 11 levels by twisting cap(0.8mm-2.3mm) |
| | RC-AD-VIXT: 6 levels by adjusting<br>cap(0.3mm-1.5mm)<br>RC-AD-VII: 6 levels by adjusting<br>cap(0.7mm-2.2mm)<br>RC-AD-XI: 11 levels by adjusting<br>cap(0.3mm-1.6mm)<br>RC-AD-XII: 9 levels by adjusting<br>cap(0.4mm-1.8mm)<br>RC-AD-XIV: 9 levels by adjusting<br>cap(0.4mm-1.8mm)<br>Sinodraw: 10 levels by adjusting<br>cap(0.4mm-1.6mm)<br>RC-LD-16: 10 levels by adjusting<br>cap(0.1mm-1.5mm)<br>RC-LD-17: 5 levels by adjusting<br>cap(0.1mm-1.5mm)<br>RC-LD-18: 10 levels by adjusting<br>cap(0.1mm-1.5mm)<br>RC-LD-19: 10 levels by adjusting<br>cap(0.1mm-1.5mm) | |
| Mechanical<br>loading | Spring-driven | Spring-driven |
| Load and<br>firing | ● Load by pressing priming button<br>when lancet is inserted,<br>● Fire by pressing the release button. | ● Load by pressing priming button when<br>lancet is inserted,<br>● Fire by pressing the release button. |
| Anatomical<br>sites | ● Fingertip<br>● Ball of the hand (palm)<br>● Upper arm<br>● Lower arm (forearm) | ● Fingertip<br>● Ball of the hand (palm)<br>● Upper arm<br>● Lower arm (forearm) |
| Sharps<br>injury<br>prevention | Lancets are covered by a sterile barrier<br>cap until twisted off before use. Until<br>firing, the lancet is contained within the<br>lancing device housing. Immediately<br>after firing, the lancet is automatically<br>retracted back into housing. An ejector<br>sleeve can then be pulled forward for<br>contactless disposal of the lancet | Lancets are covered by a sterile barrier cap<br>until twisted off before use. Until firing,<br>the lancet is contained within the lancing<br>device housing. Immediately after firing,<br>the lancet is automatically retracted back<br>into housing. An ejector sleeve can then be<br>pulled forward for contactless disposal of<br>the lancet |

#### 8. Technological Comparison [21 CFR 807.92(a)(6)]

The RightLance Blood Lancing System and predicate device share the same e technological characteristics including their design, mechanical mechanism, principle of operation, energy source Page 2 of 5

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and usage, features, form, fit, and function.

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### 9. Non-Clinical Testing Summary [21 CFR 807.92(b)]

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

The test results demonstrated that the proposed device complies with its design specification. The bench testing performed shown as following:

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 10993-4:2017, Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood

ISO 11137-2, Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose - Method VD max.

USP34<151>, Rabbit Pyrogen Test

Performance Testing - Basic Size

Performance Testing - Puncture Depth

Performance Testing - Lancing Device Cap Removal

Performance Testing - Lancing Device Firing Force

Performance Testing - Drop

Performance Testing - Drawing Force

Performance Testing - The tightness of lancing device

Shelf Life (aging) Validation

- 10. Clinical Testing [21 CFR 807.92(b)] Clinical Testing is not applicable;
- 11. Conclusions [21 CFR 807.92(b)]

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.