The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.

Device Description

The Renew Insert is a simple, easy to use device consisting of two components: a soft silicone insert and a plastic fingertip applicator. The Insert is soft and easily deformable, making it safe and comfortable to use. The applicator is flexible and is preassembled inside the Insert and does not come in contact with the anal canal. Renew Inserts are available in two sizes, Regular and Large to accommodate a range of anatomies and incontinence severities. Users are instructed to start with the Regular size and move to the Large size if they experience an inadvertent loss of the Insert or stool leakage around the Insert. The device is provided and non-sterile in individual, single-use blister packs.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the Renew Insert meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the effectiveness endpoints of the pivotal study. The "reported device performance" refers to the results achieved in that study.

Acceptance Criterion (Implicit)	Reported Device Performance
Effectiveness:
Reduction in Accidental Bowel Leakage (ABL) frequency	Median ABL reduction of 81.8% compared to baseline (Modified ITT Cohort, n=85). Daily mean ABL reduced from 1.13 ± 0.849 episodes/day at baseline to 0.29 ± 0.376 episodes/day post-treatment.
Reduction in post-treatment Wexner scores	Median Wexner Score reduction of 29.4% (Modified ITT Cohort, n=77 with both pre/post scores). Median Wexner score reduced from 16.0 at baseline to 11.0 post-treatment.
Safety:
Absence of Insert-related serious adverse events	No events rated as severe, nor were there any reported serious, unanticipated adverse events. Over half of subjects (50.5%) experienced some adverse events (AEs), with 64.6% of these assessed as 'probable' or 'possible' related to Insert use. Almost all (98.7%) of these possible AEs were rated as 'mild'.
Absence of any serious irritation of anal canal/lower rectal mucosa	Normal digital rectal exams in 100% of subjects (n=77). Anoscopic rectal exam results were normal in 97.4% of subjects, and 2.6% of treated subjects had abnormal exams determined not Insert-related.
Usability/Tolerability:
User satisfaction/ease of use	Overall satisfaction rated 4.7 on a 5-point scale in usability evaluation. In the pivotal study, 91.4% of subjects rated overall experience and ease of use as 9.5 (median) on a 10-point scale. Subjects were able to use the Renew Insert without difficulty. Pilot trial: Ease of insertion rated 9.13 on a 1-10 scale (n=22 subjects).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Effectiveness (ABL frequency): Modified ITT Cohort, n=85 subjects.
- Effectiveness (Wexner Score): Modified ITT Cohort, n=77 subjects (those with both pre-treatment and post-treatment Wexner scores).
- Safety: ITT Cohort (all subjects who used the Renew Insert at least once), n=91 subjects.
- Usability (Pivotal Study): Primarily n=85 (Modified ITT) or n=91 (ITT) for overall satisfaction.
- Usability (Pilot Study): n=22 subjects for ease of insertion.
Data Provenance: The pivotal clinical study was multi-center and conducted in the United States. It was a prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" for the test set in the traditional sense of independent reviewers adjudicating findings (e.g., image interpretation).

Instead, the study relied on:

Subject-reported outcomes: Daily diaries for ABL frequency, and self-reported Wexner scores (a validated clinical tool derived from subject reporting and physician assessment components).
Investigator observation/assessment: For adverse events, digital rectal exams, and anoscopies. The document mentions "investigators" assessed AEs, but does not specify their number or qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for the core effectiveness endpoints (ABL frequency, Wexner score). These metrics are primarily based on subject diaries and clinical assessments by the study investigators.

For safety, adverse events were "assessed by the investigators." There is no mention of an independent adjudication committee for adverse events.

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, an MRMC comparative effectiveness study was not done. The Renew Insert is a medical device (an anal insert), not an AI-powered diagnostic or assistive technology for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

This question is not applicable. The Renew Insert is a physical medical device, not an algorithm. Its performance is its direct efficacy and safety when used by patients.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is primarily based on:

Clinical outcomes data: Reduction in accidental bowel leakage (ABL) episodes (recorded in daily diaries) and improvement in Wexner scores (clinical assessment tool).
Safety outcomes data: Absence of serious adverse events and objective assessment of anal/rectal mucosa health (digital rectal exams and anoscopies).
Patient-reported outcomes: Subjective feedback on ease of use and overall satisfaction.

8. The Sample Size for the Training Set

This question is not applicable. The Renew Insert is a physical medical device, not a machine learning model that requires a "training set." The clinical studies conducted were for verification and validation of the device's performance in humans.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" for a physical medical device.

Summary

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Image /page/0/Picture/0 description: The image shows the word "Renew" in a stylized, cursive font. Above the word, there are several short, curved lines radiating upwards, resembling sun rays or a burst of energy. The overall design gives the impression of revitalization or freshness.

#KI22003 October 24, 2012

Attachment 1

510(k) Summary

Regulatory Authority

Safe Medical Devices Act of 1990, 21 CFR 807.92

Submitter Information

Company:	Renew Medical, Inc.
	532 Emerson St.
	Palo Alto, CA 94301
	Phone: 1-888-987-2929
Contact Person:	Victoria MackinnonSr. Director, Regulatory and Clinical Affairs and Quality Assurance
Summary Date:	October 24, 2012

Name and Classification

Common Name:	Anal Insert
Proprietary Name:	Renew Insert
Classification Name:	Gastrointestinal tubes and accessories
Product Code:	PBP
Regulation Number:	876.5980
Class:	II

Predicate Devices

The Renew Insert ("Insert") has the same intended use and function as commercially available medical devices:

a) Procon2; Incontinent Control Device Inc. (#K042431)

Intended Use

The Renew Insert is indicated for the management of accidental bowel leakage due to bowel The Renew Insert is designed for self-insertion to seal and help prevent the incontinence. involuntary leakage of stool from the rectum.

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Description of Device

Summary of Technological Characteristics

The Renew Insert is self-inserted by the user through the anus into the anal canal. The top disk of the Insert rests against the bottom of the rectum to help prevent bowel leakage. The elastic stem of the Insert spans the anal canal and the bottom disk keeps the Insert in place by resting against the outer part of the anus. The removable fingertip applicator is flexible to allow easy insertion of the Insert. The insert is naturally expelled with voluntary bowel movement, or if desired, can be manually removed by the user.

Performance Testing

The Renew Insert has been verified for performance and functionality and tested to assure conformance to the requirements for its intended use.

The following performance tests were performed on the Renew Insert and its packaging:

. Tensile testing
. Detachment testing
. Puncture testing
. Buckling testing
. Bending testing
. Package integrity testing

Biocompatibility Testing

The biocompatibility of the Renew Insert was assessed in accordance with ISO 10993-1- Biological evaluation of medical devices, Part 1 – Evaluation and tests within a risk management process.

The biocompatibility tests listed below were conducted on the Renew Insert in accordance with the provisions of the FDA GLP regulations 21 CFR Part 58.

. Cytotoxicity
Sensitization .
Irritation
Rectal Irritation with Histology
. Systemic Toxicity
Genotoxicity

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The biocompatibility test results confirmed that the Renew Insert is non-cytotoxic, non-sensitizing, non-irritating, non-toxic, and non-mutagenic when evaluated under the respective test conditions described in ISO 10993.

Usability Evaluation

User assessment evaluations were conducted by consumer panelists under actual use conditions to verify ease of use. On a 5 point scale, overall satisfaction was rated a 4.7. The users were able to use the Renew Insert without difficulty. Usability testing demonstrated the Renew Insert performs as designed and intended.

Clinical Studies

Pilot and pivotal clinical studies were conducted in Europe and in the United States to demonstrate the tolerability, safety and effectiveness of the Renew Insert. Users were required to follow the instructions provided, be capable of self-inserting the Renew Insert during the study, and complete daily diaries to record their episodes of accidental bowel leakage.

A pilot trial was conducted in the US with 22 subjects. These subjects rated the ease of insertion as 9.13 using a scale of 1-10.

Pivotal Study Summary

Renew Medical conducted a multi-center, prospective, open label, single-arm, non-randomized pivotal study designed to establish the safety, effectiveness, and tolerability of the Renew Insert in subjects with moderate-to-severe bowel incontinence (defined as having a Wexner score greater than 12). Three (3) clinical sites participated in the US pivotal trial, enrolling a total of ninety-seven (97) subjects. The trial consisted of a 4-week baseline evaluation period, a 12-week treatment period and a 4-week return to baseline period.

For effectiveness, changes to accidental bowel leakage (ABL) were measured by the following two endpoints:

reduction in ABL frequency (by comparing treatment results to pre-treatment results from the Baseline Period); and
reduction in post-treatment Wexner scores [by comparing post-treatment Wexner scores to pre-treatment (end of Baseline Period) Wexner scores].

The two safety endpoints of the study included:

absence of Insert-related serious adverse events (primary); and
absence of any serious irritation of the anal canal or lower rectal mucosa from the use of the Insert during the study period (secondary).

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Analysis Cohorts

The Baseline Period was included in the study design to establish the severity of each subject's baseline bowel incontinence (BI) condition, and to establish the frequency and severity of ABL for each subject. At the end of 4 weeks, subjects who continued to meet inclusion criteria were enrolled in the Treatment Period.

All subjects enrolled in the Treatment Period had at least one exposure to the Insert. Therefore, the Intent-to-Treat ("ITT") cohort and the Safety Cohort included the same group of subjects: all subjects who used the Renew Insert at least once during the Treatment Period of the study.

The primary cohort for the effectiveness analyses was the Modified Intent-To-Treat ("Modified ITT") Cohort. Subjects were getting acclimated to the Insert during the first few days of use and tried different sizes of Inserts (regular or large) for comfort and effectiveness. Therefore, the Modified ITT Cohort included all subjects who completed at least one week of Insert use during the 12-week Treatment Period.

Subject Disposition and Demographics

Ninety-seven (97) subjects enrolled in the study. Six (6) of the 97 enrolled subjects discontinued participation during the pre-treatment Baseline Period; 4 subjects did not meeting eligibility criteria and 2 subjects found the protocol too demanding.

Ninety-one (91) subjects entered the Treatment Period. Of these 91 subjects, 90.1% were female, with a mean age of 68.6 years (range from 33.9 to 88.9 years).

These 91 treated subjects were considered as the "ITT Cohort" for the safety endpoints. Of the 91 subjects entering the treatment phase, 6 subjects discontinued study participation before completing week 1. Reasons for discontinuation included: 2 found the protocol too demanding, 2 subjects with pre-existing hemorrhoids made Insert use uncomfortable, and 2 subjects experienced loss of the Renew Insert during urination or from excess anal mucous.

As stated previously, the Modified ITT Cohort included all subjects who completed at least one week of Insert use during the 12-week Treatment Period. The Modified ITT group was a net population of 85 subjects (as the 6 subjects who withdrew during week 1 were excluded). Effectiveness results are reported on this cohort of subjects.

Effectiveness Analysis Results: Summary of ABL Study Endpoints

Reduction in ABL was analyzed on the 85 subjects in the Modified ITT group.

During the pre-treatment Baseline Period, ABL frequency for the Modified ITT cohorts was about 8 ABL episodes per week (daily mean of 1.12 ± SD 0.849 / median 0.89 per day). After treatment with Renew Inserts, ABL was reduced to about 1 ABL episode per week. The Modified ITT had a daily mean of 0.29 ±SD 0.376 / median 0.17, and a median ABL reduction of 81.8% as compared to the Baseline Period (Table 1). ·

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		ABL Results for Modified ITT Cohort
Parameter	Statistic	Result(Daily)	% Change from Endof Baseline
Total Subjects	N	85
BASELINEPERIOD	MEAN +/- SD	1.13 +/- 0.849
BASELINEPERIOD	MEDIAN	0.89
BASELINEPERIOD	(Q1, Q3)	(0.54, 1.54)
BASELINEPERIOD	(MIN, MAX)	(0.14, 3.93)
Total Subjects	N	85
TREATMENTPERIOD	MEAN +/- SD	0.29 +/- 0.376	-71.4 +/- 29.879
TREATMENTPERIOD	MEDIAN	0.17	-81.8
TREATMENTPERIOD	(Q1, Q3)	(0.05, 0.37)	(-91.7, -60.3)
TREATMENTPERIOD	(MIN, MAX)	(0.00, 2.44)	(-100, 44.75)
	P VALUE (U=0)	<0.001NP	<0.001 NP

Table 1. Reduction in ABL Frequency, Modified ITT Cohort

NP = Non-parametric test

Effectiveness Analysis; Summary of Wexner Score Study Endpoints

Reduction in Wexner Score was analyzed on 77 subjects in the Modified ITT group who had both a pre-treatment and post-treatment Wexner score. In the Wexner scale, full continence is a Wexner score of zero (0) and full incontinence is a Wexner score of 20. The median Wexner Score before treatment with Renew Inserts was 16.0, whereas, the median post-treatment Wexner score was 11.0. There was a 29.4% median reduction in the Wexner score, as shown in Table 2.

Parameter	Statistic	Result
Total Subjects	N	85
End ofBASELINEPERIOD	MEAN +/- SD	16.2 +/- 2.10
	MEDIAN	16.0
	(Q1, Q3)	(15.0, 18.0)
	(MIN, MAX)	(12.0, 20.0)
		<0.001 NP
Total Subjects	N	77

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	MEAN +/- SD	10.9 +/- 4.36	-32.4 +/- 25.77
End ofTREATMENTPERIOD	MEDIAN	11.0	-29.4
	(Q1, Q3)	(8.0, 14.0)	(-46.2, -13.3)
	(MIN, MAX)	(0.0, 19.0)	(-100, 18.8)
		<0.001 NP	<0.001 NP

NP = Non-parametric test

Safety Analysis

Safety was evaluated on any subject who used at least one (1) Renew Insert. Over half of the subjects experienced some adverse events (AE), with 64.6% of the events assessed by the investigators as 'probable' or 'possible' related to the use of the Insert. There were no events rated as severe, nor were there any reported serious, unanticipated adverse events. Almost all (98.7%) of these possible adverse events were rated as mild'. Table 3 summarizes the most frequently reported adverse events by severity.

Due to the nature of Accidental Bowel Leakage (ABL), the anorectal area is particularly sensitive and irritated due to frequent stool discharge. Anorectal events were the most frequent, 'probable/possible' related AEs among all treated subjects. Of these, the sensation of urge was reported by 26.4% of subjects and irritation reported by 13.2% of subjects.

Toble 3. Summary of "Possible or Probable" (Insert) Related Adverse Event Types, Rated Severity and Frequency in the Safety Cohort (N=91)

	Severity of AE - (%)			Subjects(%)
	Mild	Moderate	Severe
% of Subjects with Possible/ProbableRelated Adverse Event	(48.4%)	(2.2%)	(0.0%)	(50.5%)
Anorectal (All)	(35.2%)	(2.2%)	(0.0%)	(37.4%)
Urge	(25.3%)	(1.1%)	(0.0%)	(26.4%)
Irritation	(13.2%)	(0.0%)	(0.0%)	(13.2%)
GI Disorders (all)	(11.0%)	(0.0%)	(0.0%)	(11.0%)
Discomfort	(4.4%)	(0.0%)	(0.0%)	(4.4%)
Gas	(3.3%)	(0.0%)	(0.0%)	(3.3%)
Hemorrhoids (All)	(4.4%)	(1.1%)	(0.0%)	(5.5%)

Note: At each level of summation, subjects are counted only once. Subjects experiencing adverse events of more than one severity are summarized according to the maximum severity experienced over all episodes of an adverse event.

In addition to the above adverse events, Insert displacement was also experienced and reported as a device-related event (see Table 4). Displacement of the Insert is when the lower (bottom) disk of the Insert becomes temporarily displaced and moves upward into the anus. Two subjects reported 60.3% of all displacement events; one subject had a pre-existing anal sphincter tear and another subject experienced displacement after strenuous physical exercise. Instances of displacement were predominately resolved by natural expulsion during subsequent bowel movements.

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#K122003 October 24, 2012

Table 4. Device Related Event: Insert Displacement

	Severity of Displacement - N (%)			Subjects
	Mild	Moderate	Severe	N (%)
Subjects Reporting Displacement AE	21 (23.9%)	(0.0%)	(0.0%)	21 (23.9%)
Number of Displacement Events	(31.4%)	(0.0%)	(0.0%)	(31.4%)

An additional safety endpoint of the study was absence of any serious irritation of the anal or lower rectal mucosa. Pre-treatment and end of treatment anal canal and lower rectal mucosa evaluations (digital rectal examinations and anoscopies) were performed in 77 subjects. [Eight subjects could not or would not come in to have an end of treatment rectal exam. ]

End of treatment anal canal and lower rectal mucosa evaluations showed normal digital rectal exams in 100% of the subjects. Anoscopic rectal exam results were normal in 97.4% of subjects, and 2.6% of the treated subjects were found with abnormal exams, and determined not Insert-related.

Overall satisfaction among the majority of Insert users was high and 91.4% of the subjects rated overall experience and ease of use as 9.5 (median) on a 10-point scale.

Overall, the clinical evaluation pivotal study demonstrated that the Renew Insert is comfortable to wear, highly effective, and offers an easy to use device for managing ABL. In the modified ITT treatment group, clinical results demonstrate a median ABL reduction of 81.8%, and a median reduction of 29.4% in the Wexner score. Adverse events reported were predominantly mild in nature, with no reported severe, serious, or unanticipated adverse events. The Renew Insert performs as intended to reduce the frequency of, and help prevent accidental bowel leakage, and is safe and effective for its intended use.

Conclusion

Design verification and validation testing confirmed that no new questions of safety or effectiveness were identified during testing. Performance testing and clinical studies demonstrated that the Renew Insert is easy to use, performs as intended to reduce the frequency of accidental bowel leakage, and is safe and effective for its intended use.

The Renew Insert is substantially equivalent in intended uses, technological characteristics, and principles of operation to the Procon2 device cleared under the Federal Food, Drug and Cosmetic Act. The minor technological differences between the Renew Insert and its predicate devices raise no new issues of safety or effectiveness, and is, therefore, substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of providing essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Ms. Victoria Mackinnon Sr. Director Regulatory/Clinical/Quality Assurance Renew Medical, Inc. 532 Emerson Street PALO ALTO CA 94301

OCT
26 2012

Re: K122003

Trade/Device Name: Renew Insert Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: PBP Dated: September 26, 2012 Received: September 27, 2012

Dear Ms. Mackinnon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed four becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use statou in the encreations of to the enactment date of the Medical Device Amendments, or to conimeres proct to may 20, 1977, as accordance with the provisions of the Federal Food, Drug, de neces that have been rocasion of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrore, mains of the Act include requirements for annual registration, listing of general voluroly provisioning practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Y lease nover, 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 1 toase oc determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny reading buttor 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

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerély yours,

Sincerely yours,

Benjamin K. Evans

Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/9/Picture/0 description: The image shows the word "Renew" in a stylized, cursive font. Above the word, there is a graphic of a sun with rays emanating upwards, suggesting a sense of revitalization or freshness. The overall design is simple yet elegant, conveying a feeling of renewal or rejuvenation.

#K122003, Amendment 2 October 17, 2012

Attachment 2

Indications for Use

510(k) Number: K122003

Renew Insert Device Name:

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) and/or

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K122003

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Regulation Number and Section

§ 876.5980 Gastrointestinal tube and accessories.

(a)
Identification. A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).(b)
Classification. (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.